DOTT: Diabetes-Obstructive Sleep Apnea Treatment Trial
Sponsor
Eileen R. Chasens (Other)
Overall Status
Terminated
CT.gov ID
NCT01901055
Collaborator
(none)
98
4
2
62.8
24.5
0.4
Study Details
Study Description
Brief Summary
Diabetes self-management is important to help adults with type 2 diabetes achieve glucose control. Obstructive sleep apnea often co-exists with type 2 diabetes and may act as a barrier to diabetes self-management and glucose control. We will examine if treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP), combined with diabetes education, results in improved diabetes self-management and glucose control.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
While diabetes self-management has been improved and refined over the last 30 years, many persons with T2DM continue to have difficulty in achieving glycemic goals. Obstructive sleep apnea (OSA) has a high prevalence among adults with type 2 diabetes (T2DM) and is associated with excessive daytime sleepiness, impaired mood, decreased vigilance, and reduced functional outcomes. The degree that OSA affects diabetes self-management, a known determinant of glycemic control, remains unstudied.
The most effective treatment for OSA, continuous positive airway pressure (CPAP), results in improved self-reported daytime functioning. However, the effect of CPAP treatment on reception of diabetes education remains unknown. The underlying premise of the proposed study from this new investigator is that OSA hinders diabetes self-management in adults with T2DM.
Our goal is to improve understanding of the effect of OSA on diabetes self-management and to determine the efficacy of CPAP treatment in improving diabetes outcomes in adults treated with CPAP compared to those on sham-CPAP. Expanding our understanding of the effect of sleep disturbances on diabetes self-management may lead to improved guidelines for screening and treatment of OSA in the increasingly large portion of the population with diabetes
Study Design
Study Type:
Interventional
Actual Enrollment
:
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel was a one-way cross over after 12 weeks with persons originally in the sham group being titrated onto active CPAP.Parallel was a one-way cross over after 12 weeks with persons originally in the sham group being titrated onto active CPAP.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Treatment of Obstructive Sleep Apnea on Diabetes Self Management and Glycemic Control
Actual Study Start Date
:
Feb 13, 2014
Actual Primary Completion Date
:
May 8, 2019
Actual Study Completion Date
:
May 8, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active CPAP treatment Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) |
Device: CPAP
CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Other Names:
Behavioral: Diabetes Education
Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)
|
| Placebo Comparator: Sham-CPAP Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. |
Device: CPAP
CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Other Names:
Device: Sham-CPAP
Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Other Names:
Behavioral: Diabetes Education
Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)
|
Outcome Measures
Primary Outcome Measures
- HbA1C Level [baseline, 6 weeks, 12 weeks]
Glycated hemoglobin test that estimates the blood glucose level over last 2 to 3 months. Higher scores indicate worse diabetes control.
Secondary Outcome Measures
- Fructosamine Level [baseline, 6 weeks, 12 weeks]
Measurement of glucose in plasma that estimates the blood glucose level over last 10 days to 3 weeks. The normal range is from 221.00 to 451.00.
- Diabetes Diet Adherence [baseline, 6 weeks, 12 weeks]
Diabetes Diet Adherence score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that was adherent to diabetes diet, range from minimum=0 days to maximum=7 days; higher number indicates better adherence to diabetes diet
- Diabetes Knowledge [baseline,12 weeks only]
Score on the Diabetes Knowledge Test. Scores range minimum=0 to maximum=100, higher scores indicate higher knowledge (this measure only done at 12 weeks)
- Self-Monitoring of Blood Glucose (SMBG) [baseline, 6 weeks, 12 weeks]
SMBG score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that SMBG was done, range from 0 days to 7 days; higher number indicates better SMBG
- Steps Walked [baseline, 6 weeks, 12 weeks]
Average number of steps walked daily; measured by BodyMedia Armband; higher numbers indicate more steps walked. The range is from 397.83 to 16839.00.
- Self-Monitoring of Foot Care [baseline, 6 weeks, 12 weeks]
Foot Care score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that foot care was done, range from 0 days to 7 days; higher number indicates better adherence to foot care
- Diabetes-Related Distress [baseline, 6 weeks, 12 weeks]
Score of the Problem Areas in Diabetes (PAID) Questionnaire; scores range from 0-100, higher scores indicate worse diabetes-related distress.
- Sleep Quality [baseline, 6 weeks, 12 weeks]
Sleep Quality is measured by the Pittsburgh Sleep Quality Index (PSQI) - Higher scores indicate worse sleep quality. The potential range is from 0 to 27 with higher scores indicating worse sleep quality.
- Mood [baseline, 6 weeks, 12 weeks]
Mood impairment measured by the Profile of Mood States (POMS) total score; potential scores range from 0 to 60; higher scores indicate worse mood.
- Vigilance [Administered during diabetes education sessions done within the first 6 weeks of study; baseline, approximately 3 weeks after starting CPAP, and at the 2nd diabetes education session]
Ability to maintain attention (i.e. vigilance); Measured by the Psychomotor Vigilance Test primary metric being transformed lapses (i.e. when person does not respond to a visual stimuli in a reaction time test). Normal values are <=2 lapses within the 10 minute test. Higher scores indicate worse vigilance.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Suboptimal glucose control (A1C ≥ 6.5%)
-
Moderate-to-severe obstructive sleep apnea (apnea + hypopnea index >= 10/hour)
-
age 18 years and older
Exclusion Criteria:
-
Poor glucose control (A1C > 11)
-
Type 1 or gestational diabetes
-
Sleep duration < 4 hrs
-
Acute medical or surgical conditions or hospitalization ≤ 3 months
-
Oxygen or bi-level PAP required
-
Prior CPAP or persons in household with CPAP
-
Employed in safety sensitive job
-
Pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | John D. Dingell VAMC | Detroit | Michigan | United States | 48201 |
| 2 | Pittsburgh Veterans Administration Medical Center | Pittsburgh | Pennsylvania | United States | 15240 |
| 3 | University of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15261 |
| 4 | West Virginia University | Morgantown | West Virginia | United States | 26506 |
Sponsors and Collaborators
- Eileen R. Chasens
Investigators
- Principal Investigator: Eileen R. Chasens, PhD, University of Pittsburgh
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Eileen R. Chasens,
Professor of Nursing,
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01901055
Other Study ID Numbers:
- 5R01DK096028-02
First Posted:
Jul 17, 2013
Last Update Posted:
Aug 16, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Eileen R. Chasens,
Professor of Nursing,
University of Pittsburgh
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants recruitment started in 2014 and the last participant was evaluated in 2019. The total sample screened (N=862) was from the University of Pittsburgh (n=720), Veterans Administration Pittsburgh Healthcare System (n=58), West Virginial University (n=72), and the John Dingell Detroit Veterans Administration Healthcare System (n=12). |
|---|---|
| Pre-assignment Detail | Phone assessment excluded persons with prior CPAP use, not having diagnosis of type 2 diabetes, history of a sleepiness related accident or near miss, or not ambulatory. Participants (n=355) who met the phone screening were invited for a baseline assessment. The baseline assessment excluded persons with HbA1c either < 6.5% or > 11%; without OSA, with too high a AHI or severe oxygen desaturations, or not interested in being randomized to sham-CPAP. 98 participants meet all eligibility criteria. |
| Arm/Group Title | Active CPAP Treatment | Sham-CPAP |
|---|---|---|
| Arm/Group Description | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) |
| Period Title: Randomization But Not Titrated | ||
| STARTED | 49 | 49 |
| COMPLETED | 48 | 47 |
| NOT COMPLETED | 1 | 2 |
| Period Title: Randomization But Not Titrated | ||
| STARTED | 48 | 47 |
| COMPLETED | 45 | 43 |
| NOT COMPLETED | 3 | 4 |
| Period Title: Randomization But Not Titrated | ||
| STARTED | 45 | 43 |
| COMPLETED | 44 | 39 |
| NOT COMPLETED | 1 | 4 |
| Period Title: Randomization But Not Titrated | ||
| STARTED | 44 | 39 |
| COMPLETED | 30 | 20 |
| NOT COMPLETED | 14 | 19 |
| Period Title: Randomization But Not Titrated | ||
| STARTED | 30 | 20 |
| COMPLETED | 30 | 15 |
| NOT COMPLETED | 0 | 5 |
Baseline Characteristics
| Arm/Group Title | Active CPAP Treatment | Sham-CPAP | Total |
|---|---|---|---|
| Arm/Group Description | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) | Total of all reporting groups |
| Overall Participants | 49 | 49 | 98 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
31
63.3%
|
38
77.6%
|
69
70.4%
|
| >=65 years |
18
36.7%
|
11
22.4%
|
29
29.6%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
60.08
(10.13)
|
57.37
(9.32)
|
58.72
(9.78)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
23
46.9%
|
19
38.8%
|
42
42.9%
|
| Male |
26
53.1%
|
30
61.2%
|
56
57.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
1
2%
|
1
2%
|
2
2%
|
| Not Hispanic or Latino |
48
98%
|
48
98%
|
96
98%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
2%
|
1
1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
13
26.5%
|
8
16.3%
|
21
21.4%
|
| White |
36
73.5%
|
37
75.5%
|
73
74.5%
|
| More than one race |
0
0%
|
3
6.1%
|
3
3.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
49
100%
|
49
100%
|
98
100%
|
| HbA1c (percentage of glycated hemoglobins) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [percentage of glycated hemoglobins] |
7.73
(0.75)
|
8.04
(1.01)
|
7.89
(0.90)
|
| Fructosamine (µmol/L) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [µmol/L] |
285.10
(45.20)
|
301.88
(54.41)
|
293.59
(50.48)
|
| Body Mass Index (kg/m^2) (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
35.71
(6.16)
|
36.69
(6.99)
|
36.20
(6.57)
|
| Apnea-Hypopnea Index (events per hour of sleep) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [events per hour of sleep] |
22.48
(13.41)
|
25.92
(15.86)
|
24.20
(14.71)
|
| Epworth Sleepiness Scale (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
10.22
(4.36)
|
10.39
(4.76)
|
10.31
(4.54)
|
| Pittsburgh Sleep Quality Index Total Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
10.00
(3.61)
|
9.67
(4.19)
|
9.84
(3.89)
|
Outcome Measures
| Title | HbA1C Level |
|---|---|
| Description | Glycated hemoglobin test that estimates the blood glucose level over last 2 to 3 months. Higher scores indicate worse diabetes control. |
| Time Frame | baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants were analyzed (the intention to treat method). |
| Arm/Group Title | Active CPAP Treatment | Sham-CPAP Treatment |
|---|---|---|
| Arm/Group Description | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. |
| Measure Participants | 49 | 49 |
| Baseline |
7.73
(0.13)
|
8.04
(0.13)
|
| 6-week |
7.49
(0.17)
|
820
(0.17)
|
| 12-week |
7.46
(0.15)
|
7.80
(0.16)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Active CPAP Treatment, Sham-CPAP Treatment |
|---|---|---|
| Comments | Statistical analyses were revised from the original protocol for reporting results at 24 week because unable to recruit an adequate sample size at this time point of participants originally on CPAP for 24 weeks and those who were in the original sham-CPAP group who crossed over to CPAP and completed 24 weeks of treatment. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.017 |
| Comments | F-test statistics for group X time = 4.27 | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.32 | |
| Confidence Interval |
(2-Sided) 95% -0.68 to 0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | Treatment Difference = Active CPAP - Sham CPAP | |
| Title | Fructosamine Level |
|---|---|
| Description | Measurement of glucose in plasma that estimates the blood glucose level over last 10 days to 3 weeks. The normal range is from 221.00 to 451.00. |
| Time Frame | baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants with data were analyzed (the intention to treat method). Unable to obtain laboratory value on from participants from West Virginia University (n=12), Detroit (n=1), and Pitt (n=2) |
| Arm/Group Title | Active CPAP Treatment | Sham-CPAP |
|---|---|---|
| Arm/Group Description | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) |
| Measure Participants | 41 | 42 |
| Baseline |
285.94
(7.78)
|
300.99
(7.68)
|
| 6-week |
272.84
(7.32)
|
293.73
(7.53)
|
| 12-week |
274.87
(7.53)
|
285.56
(7.80)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Active CPAP Treatment, Sham-CPAP Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.307 |
| Comments | F test statistics for group X time = 1.20 | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -16.78 | |
| Confidence Interval |
(2-Sided) 95% -38.66 to 5.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 10.99 |
|
| Estimation Comments | Treatment Difference = Active CPAP - Sham CPAP | |
| Title | Diabetes Diet Adherence |
|---|---|
| Description | Diabetes Diet Adherence score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that was adherent to diabetes diet, range from minimum=0 days to maximum=7 days; higher number indicates better adherence to diabetes diet |
| Time Frame | baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants with valid data were analyzed (the intention to treat method). One participant with missing data. |
| Arm/Group Title | Active CPAP Treatment | Sham-CPAP |
|---|---|---|
| Arm/Group Description | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) |
| Measure Participants | 49 | 48 |
| Baseline |
3.55
(0.29)
|
3.61
(0.30)
|
| 6-week |
4.18
(0.27)
|
4.05
(0.29)
|
| 12-week |
4.30
(0.25)
|
4.05
(0.27)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Active CPAP Treatment, Sham-CPAP Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.732 |
| Comments | F test statistics for group X time = 0.31 | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.25 | |
| Confidence Interval |
(2-Sided) 95% -0.85 to 0.35 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.30 |
|
| Estimation Comments | Treatment Difference = Active CPAP - Sham CPAP | |
| Title | Diabetes Knowledge |
|---|---|
| Description | Score on the Diabetes Knowledge Test. Scores range minimum=0 to maximum=100, higher scores indicate higher knowledge (this measure only done at 12 weeks) |
| Time Frame | baseline,12 weeks only |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants were analyzed (the intention to treat method). |
| Arm/Group Title | Active CPAP Treatment | Sham-CPAP |
|---|---|---|
| Arm/Group Description | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) |
| Measure Participants | 49 | 49 |
| Baseline |
79.39
(1.88)
|
75.74
(1.88)
|
| 12-week |
83.20
(1.79)
|
79.81
(1.88)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Active CPAP Treatment, Sham-CPAP Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.919 |
| Comments | F test statistics for group X time = 0.01 | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 3.65 | |
| Confidence Interval |
(2-Sided) 95% -1.62 to 8.92 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.65 |
|
| Estimation Comments | Treatment Difference = Active CPAP - Sham CPAP | |
| Title | Self-Monitoring of Blood Glucose (SMBG) |
|---|---|
| Description | SMBG score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that SMBG was done, range from 0 days to 7 days; higher number indicates better SMBG |
| Time Frame | baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants were analyzed (the intention to treat method). |
| Arm/Group Title | Active CPAP Treatment | Sham-CPAP |
|---|---|---|
| Arm/Group Description | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) |
| Measure Participants | 49 | 49 |
| Baseline |
4.17
(0.38)
|
4.24
(0.38)
|
| 6-week |
5.44
(0.31)
|
5.10
(0.33)
|
| 12-week |
5.52
(0.34)
|
4.61
(0.36)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Active CPAP Treatment, Sham-CPAP Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.125 |
| Comments | F-test statistics for group X time = 2.12 | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.11 | |
| Confidence Interval |
(2-Sided) 95% -1.18 to 0.96 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.54 |
|
| Estimation Comments | Treatment Difference = Active CPAP - Sham CPAP | |
| Title | Steps Walked |
|---|---|
| Description | Average number of steps walked daily; measured by BodyMedia Armband; higher numbers indicate more steps walked. The range is from 397.83 to 16839.00. |
| Time Frame | baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants were analyzed (the intention to treat method). |
| Arm/Group Title | Active CPAP Treatment | Sham-CPAP |
|---|---|---|
| Arm/Group Description | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) |
| Measure Participants | 49 | 49 |
| Baseline |
4550.83
(374.15)
|
4463.61
(374.15)
|
| 6-week |
4774.81
(386.56)
|
4240.42
(403.84)
|
| 12-week |
4741.43
(355.27)
|
4403.97
(372.96)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Active CPAP Treatment, Sham-CPAP Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.639 |
| Comments | F-test statistics for group X time = 0.45 | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 87.22 | |
| Confidence Interval |
(2-Sided) 95% -936.10 to 1137.50 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 529.10 |
|
| Estimation Comments | Treatment Difference = Active CPAP - Sham CPAP | |
| Title | Self-Monitoring of Foot Care |
|---|---|
| Description | Foot Care score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that foot care was done, range from 0 days to 7 days; higher number indicates better adherence to foot care |
| Time Frame | baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants were analyzed (the intention to treat method). |
| Arm/Group Title | Active CPAP Treatment | Sham-CPAP |
|---|---|---|
| Arm/Group Description | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) |
| Measure Participants | 49 | 49 |
| Baseline |
3.26
(0.35)
|
3.89
(0.35)
|
| 6-week |
3.56
(0.37)
|
4.44
(0.39)
|
| 12-week |
4.18
(0.37)
|
4.57
(0.39)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Active CPAP Treatment, Sham-CPAP Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.461 |
| Comments | F-test statistics for group X time = 0.78 | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.63 | |
| Confidence Interval |
(2-Sided) 95% -1.61 to 0.35 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.49 |
|
| Estimation Comments | Treatment Difference = Active CPAP - Sham CPAP | |
| Title | Diabetes-Related Distress |
|---|---|
| Description | Score of the Problem Areas in Diabetes (PAID) Questionnaire; scores range from 0-100, higher scores indicate worse diabetes-related distress. |
| Time Frame | baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants were analyzed (the intention to treat method). |
| Arm/Group Title | Active CPAP Treatment | Sham-CPAP |
|---|---|---|
| Arm/Group Description | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) |
| Measure Participants | 49 | 49 |
| Baseline |
29.18
(2.77)
|
26.44
(2.79)
|
| 6-week |
22.75
(2.72)
|
20.08
(2.81)
|
| 12-week |
20.7413
(2.60)
|
19.99
(2.76)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Active CPAP Treatment, Sham-CPAP Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.776 |
| Comments | F-test statistics for group X time= 0.25 | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 3.04 | |
| Confidence Interval |
(2-Sided) 95% -4.78 to 10.86 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.94 |
|
| Estimation Comments | Treatment Difference = Active CPAP - Sham CPAP | |
| Title | Sleep Quality |
|---|---|
| Description | Sleep Quality is measured by the Pittsburgh Sleep Quality Index (PSQI) - Higher scores indicate worse sleep quality. The potential range is from 0 to 27 with higher scores indicating worse sleep quality. |
| Time Frame | baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants were analyzed (the intention to treat method). |
| Arm/Group Title | Active CPAP Treatment | Sham-CPAP |
|---|---|---|
| Arm/Group Description | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) |
| Measure Participants | 49 | 49 |
| Baseline |
10.00
(0.56)
|
9.67
(0.56)
|
| 6-week |
8.12
(0.52)
|
8.57
(0.54)
|
| 12-week |
8.77
(0.55)
|
8.54
(0.59)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Active CPAP Treatment, Sham-CPAP Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.378 |
| Comments | F-test statistics for group X time = 0.98 | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.33 | |
| Confidence Interval |
(2-Sided) 95% -1.24 to 1.89 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.79 |
|
| Estimation Comments | Treatment Difference = Active CPAP - Sham CPAP | |
| Title | Mood |
|---|---|
| Description | Mood impairment measured by the Profile of Mood States (POMS) total score; potential scores range from 0 to 60; higher scores indicate worse mood. |
| Time Frame | baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants were analyzed (the intention to treat method). |
| Arm/Group Title | Active CPAP Treatment | Sham-CPAP Treatment |
|---|---|---|
| Arm/Group Description | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. |
| Measure Participants | 49 | 49 |
| Baseline |
28.94
(5.12)
|
25.76
(5.12)
|
| 6-week |
17.28
(5.35)
|
23.17
(5.49)
|
| 12-week |
19.32
(5.85)
|
22.61
(6.10)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Active CPAP Treatment, Sham-CPAP Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.213 |
| Comments | F-test statistics for group X time = 1.57 | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 3.18 | |
| Confidence Interval |
(2-Sided) 95% -11.19 to 17.56 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 7.24 |
|
| Estimation Comments | Treatment Difference = Active CPAP - Sham CPAP | |
| Title | Vigilance |
|---|---|
| Description | Ability to maintain attention (i.e. vigilance); Measured by the Psychomotor Vigilance Test primary metric being transformed lapses (i.e. when person does not respond to a visual stimuli in a reaction time test). Normal values are <=2 lapses within the 10 minute test. Higher scores indicate worse vigilance. |
| Time Frame | Administered during diabetes education sessions done within the first 6 weeks of study; baseline, approximately 3 weeks after starting CPAP, and at the 2nd diabetes education session |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants with data were were analyzed (the intention to treat method). This measure was not done per site protocol at West Virginia (n=12) and Detroit (n=1)), missing data from participants at Pittsburgh and VA Pittsburgh sites (n=29). |
| Arm/Group Title | Active CPAP Treatment | Sham-CPAP |
|---|---|---|
| Arm/Group Description | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) |
| Measure Participants | 33 | 33 |
| Baseline |
4.68
(0.45)
|
4.67
(0.45)
|
| Average Lapses First Diabetes Session |
4.30
(0.47)
|
3.56
(0.47)
|
| Average lapses 2nd Diabetes Education Session |
3.59
(0.54)
|
4.78
(0.54)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Active CPAP Treatment, Sham-CPAP Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | F-test statistics for group X time = 5.66 | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.006 | |
| Confidence Interval |
(2-Sided) 95% -1.27 to 1.28 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.64 |
|
| Estimation Comments | Treatment Difference = Active CPAP - Sham CPAP | |
Adverse Events
| Time Frame | Until study completion, up to 36 weeks. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Any adverse event was evaluated at the scheduled participant assessments at 6 weeks, 12 weeks, 24 weeks, and 36 weeks. | |||||
| Arm/Group Title | Active CPAP Treatment | Sham-CPAP | Active CPAP Following Sham-CPAP | |||
| Arm/Group Description | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) | Persons who completed 12-weeks on sham-CPAP, were debriefed, titrated for active CPAP | |||
All Cause Mortality |
||||||
| Active CPAP Treatment | Sham-CPAP | Active CPAP Following Sham-CPAP | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/49 (0%) | 0/49 (0%) | 0/20 (0%) | |||
Serious Adverse Events |
||||||
| Active CPAP Treatment | Sham-CPAP | Active CPAP Following Sham-CPAP | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/49 (2%) | 1/49 (2%) | 0/20 (0%) | |||
| Cardiac disorders | ||||||
| Hypertension | 1/49 (2%) | 1 | 0/49 (0%) | 0 | 0/20 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Infection in knees bilateral | 1/49 (2%) | 1 | 0/49 (0%) | 0 | 0/20 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Diagnosed with lymphoma | 0/49 (0%) | 0 | 1/49 (2%) | 1 | 0/20 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Active CPAP Treatment | Sham-CPAP | Active CPAP Following Sham-CPAP | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/49 (0%) | 2/49 (4.1%) | 0/20 (0%) | |||
| Product Issues | ||||||
| difficulty wearing mask | 0/49 (0%) | 0 | 2/49 (4.1%) | 2 | 0/20 (0%) | 0 |
Limitations/Caveats
Recruitment was negatively affected by a large number of persons screened who were ineligible because of either their, or a family member, having prior CPAP treatment. Recruitment was also affected by persons who did not want the possibility of being randomized to be on a sham-CPAP device for 12 weeks.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Eileen R. Chasens, PhD, Professor of Nursing |
|---|---|
| Organization | University of Pittsburgh |
| Phone | 412-624-9380 |
| chasense@pitt.edu |
Responsible Party:
Eileen R. Chasens,
Professor of Nursing,
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01901055
Other Study ID Numbers:
- 5R01DK096028-02
First Posted:
Jul 17, 2013
Last Update Posted:
Aug 16, 2021
Last Verified:
Aug 1, 2021