Assessment of the Effect of PAP on Energy and Vitality in Mild OSA Patients: The Merge Study
Study Details
Study Description
Brief Summary
The investigators wish to prospectively determine the response to CPAP in patients presenting with mild OSA. In many healthcare systems, patients with mild OSA (AHI 5-15) are not reimbursed for treatment. Although some evidence exists of the benefits of treating mild OSA when scoring as per AASM 2007 criteria, more evidence is needed. The investigators wish to add to this pool of knowledge and also increase the inclusion criteria to include the AASM 2012 definition of mild OSA. By including the 2012 AASM definition of mild OSA, the investigators will add novel information to the field by assessing the benefits of treatment in both sub-groups of mild OSA.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Patients who visit their local sleep service for OSA investigation, and are found to have mild OSA (AHI ≤ 15) from an Apnealink polygraphy (PG) home sleep test, scored as per AASM 2007 and/or AASM 2012, will be invited to take part in the study (pre-screening).
At the study visit, informed consent, baseline demographics, and standardised questionnaires will be administered. Participants will then be randomised to a CPAP treatment group or control group.
After 3 months, participants will be asked to repeat the standardised questionnaires, the trial will then be complete and they will return to routine clinical care.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Continous Positive Airway Pressure Participants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial |
Device: Continous Positive Airway Pressure
CPAP refers to the application of positive airway pressure through a mask and tubing to splint a patients throat open at night. CPAP is considered standard treatment for OSA
Other Names:
|
| Placebo Comparator: Control Group Participants will receive standard care (Sleep hygiene counseling) during the study. |
Other: Control Group
Standard sleep hygiene counseling as per published guidelines
|
Outcome Measures
Primary Outcome Measures
- Change in Quality of Life Using the Energy and Vitality Subscale of the Short Form 36 (SF-36) Questionnaire [3 months]
The Short Form 36 (SF-36) questionnaire measures quality of life through a range of questions asking about patients physical and mental functioning. Specifically, the Energy and Vitality subscale records patients perceptions of their levels of energy and fatigue. Participants were administered the Short Form 36 (SF-36) questionnaire at baseline and 3 months. The change in score (value at 3 months minus value at baseline) was compared between the CPAP group and the Control group. In the SF-36 Energy and Vitality subscale, an increase in score indicates improvement, with a minimum score of 0 and a maximum score of 100 possible.
Eligibility Criteria
Criteria
Study Inclusion Criteria
-
Aged ≥ 18 and ≤ 80
-
Ability and willingness to provide written informed consent
-
AHI ≤ 15 as per AASM 2007 scoring criteria
-
Ability to tolerate a CPAP one hour long run in test
Exclusion Criteria:
-
The presence of unstable cardiac disease
-
Inability to give fully informed consent
-
Supplemental oxygen
-
Secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, obesity hypoventilation syndrome
-
ESS ≥ 15, or concerns about sleepy driving from physician/ sleep lab staff
-
BMI ≥ 40
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Freeman Hospital | Newcastle upon Tyne | Newcastle | United Kingdom | |
| 2 | Blackpool Teaching Hospital | Blackpool | United Kingdom | ||
| 3 | Papworth Hospital | Cambridge | United Kingdom | ||
| 4 | Tayside Health Board, Ninewells Hospital | Dundee | United Kingdom | ||
| 5 | Aintree University Hospital | Liverpool | United Kingdom | ||
| 6 | Royal Brompton Hospital, Imperial College London | London | United Kingdom | SW3 6NP | |
| 7 | Guys & St Thomas Hospital | London | United Kingdom | ||
| 8 | Oxford Centre for Respiratory Medicine | Oxford | United Kingdom | ||
| 9 | Derriford Hospital | Plymouth | United Kingdom | ||
| 10 | Lister Hospital | Stevenage | United Kingdom | ||
| 11 | Taunton and Somerset Hospital | Taunton | United Kingdom |
Sponsors and Collaborators
- ResMed
Investigators
- Principal Investigator: Mary Morrell, Prof, Imperial College London
Study Documents (Full-Text)
More Information
Publications
None provided.- MA200216
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 301 participants were randomised. 233 patients formed the primary analysis group. Of those, 115 were allocated to the CPAP group and 118 were allocated to standard care. The remaining 68 patients were not analysed as part of the primary analysis but were analysed for secondary analysis. |
| Arm/Group Title | Continous Positive Airway Pressure | Control Group |
|---|---|---|
| Arm/Group Description | Participants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial Continous Positive Airway Pressure: CPAP refers to the application of positive airway pressure through a mask and tubing to splint a patients throat open at night. CPAP is considered standard treatment for OSA | Participants will receive standard care (Sleep hygiene counseling) during the study. Control Group: Standard sleep hygiene counseling as per published guidelines |
| Period Title: Overall Study | ||
| STARTED | 115 | 118 |
| COMPLETED | 100 | 109 |
| NOT COMPLETED | 15 | 9 |
Baseline Characteristics
| Arm/Group Title | Continous Positive Airway Pressure | Control Group | Total |
|---|---|---|---|
| Arm/Group Description | Participants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial Continous Positive Airway Pressure: CPAP refers to the application of positive airway pressure through a mask and tubing to splint a patients throat open at night. CPAP is considered standard treatment for OSA | Participants will receive standard care (Sleep hygiene counseling) during the study. Control Group: Standard sleep hygiene counseling as per published guidelines | Total of all reporting groups |
| Overall Participants | 115 | 118 | 233 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
50.6
(11.3)
|
50.2
(12.1)
|
50.4
(11.7)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
34
29.6%
|
37
31.4%
|
71
30.5%
|
| Male |
81
70.4%
|
81
68.6%
|
162
69.5%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| white |
105
91.3%
|
103
87.3%
|
208
89.3%
|
| non-white |
10
8.7%
|
15
12.7%
|
25
10.7%
|
Outcome Measures
| Title | Change in Quality of Life Using the Energy and Vitality Subscale of the Short Form 36 (SF-36) Questionnaire |
|---|---|
| Description | The Short Form 36 (SF-36) questionnaire measures quality of life through a range of questions asking about patients physical and mental functioning. Specifically, the Energy and Vitality subscale records patients perceptions of their levels of energy and fatigue. Participants were administered the Short Form 36 (SF-36) questionnaire at baseline and 3 months. The change in score (value at 3 months minus value at baseline) was compared between the CPAP group and the Control group. In the SF-36 Energy and Vitality subscale, an increase in score indicates improvement, with a minimum score of 0 and a maximum score of 100 possible. |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Continous Positive Airway Pressure | Control Group |
|---|---|---|
| Arm/Group Description | Participants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial Continous Positive Airway Pressure: CPAP refers to the application of positive airway pressure through a mask and tubing to splint a patients throat open at night. CPAP is considered standard treatment for OSA | Participants will receive standard care (Sleep hygiene counseling) during the study. Control Group: Standard sleep hygiene counseling as per published guidelines |
| Measure Participants | 115 | 118 |
| Mean (95% Confidence Interval) [score on a scale] |
7.5
|
0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Continous Positive Airway Pressure, Control Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | The calculated p-value was <0.01 | |
| Method | ANCOVA | |
| Comments | ||
Adverse Events
| Time Frame | 3 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Continous Positive Airway Pressure | Control Group | ||
| Arm/Group Description | Participants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial Continous Positive Airway Pressure: CPAP refers to the application of positive airway pressure through a mask and tubing to splint a patients throat open at night. CPAP is considered standard treatment for OSA | Participants will receive standard care (Sleep hygiene counseling) during the study. Control Group: Standard sleep hygiene counseling as per published guidelines | ||
All Cause Mortality |
||||
| Continous Positive Airway Pressure | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/115 (0%) | 0/118 (0%) | ||
Serious Adverse Events |
||||
| Continous Positive Airway Pressure | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/115 (0.9%) | 2/118 (1.7%) | ||
| Cardiac disorders | ||||
| hospitalization for dizziness, existing cardiac condition | 0/115 (0%) | 0 | 1/118 (0.8%) | 1 |
| symptoms of transient ischemic attack (TIA) | 0/115 (0%) | 0 | 1/118 (0.8%) | 1 |
| Vascular disorders | ||||
| Stroke | 1/115 (0.9%) | 1 | 0/118 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Continous Positive Airway Pressure | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/115 (7.8%) | 13/118 (11%) | ||
| Cardiac disorders | ||||
| dizziness | 3/115 (2.6%) | 4 | 0/118 (0%) | 0 |
| General disorders | ||||
| exacerbation of pre-existing condition | 2/115 (1.7%) | 2 | 8/118 (6.8%) | 8 |
| Infections and infestations | ||||
| virus | 4/115 (3.5%) | 4 | 1/118 (0.8%) | 1 |
| Injury, poisoning and procedural complications | ||||
| physical accident | 0/115 (0%) | 0 | 3/118 (2.5%) | 3 |
| Pregnancy, puerperium and perinatal conditions | ||||
| pregnancy | 0/115 (0%) | 0 | 1/118 (0.8%) | 1 |
Limitations/Caveats
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 | Dr Alison Wimms |
|---|---|
| Organization | ResMed Ltd |
| Phone | +61 8884 1123 |
| alison.wimms@resmed.com |
- MA200216