Effect of Added Varnum Mouthpiece on Pharyngeal Collapsibility and Sleep Apnea Severity in Mouth Breathers.
Study Details
Study Description
Brief Summary
Test the effect of added a single-use Varnum mouthpiece on pharyngeal collapsibility and obstructive sleep apnea (OSA) severity in patients who identify themselves as mouth breathers. Research indicates that nasal breathing not only may improve sleep apnea but it also increases circulation, blood oxygen, and carbon dioxide levels, slows the breathing rate, and improves overall lung volumes. Thus, the investigators will test whether a single-use Varnum mouthpiece can improve pharyngeal collapsibility and OSA severity in mouth breathers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Obstructive sleep apnea (OSA) is a common disorder that remains under-treated due few therapeutic options beyond continuous positive airway pressure (CPAP). In patients with OSA, upper airway obstruction is caused by collapse of pharyngeal structures during sleep. It is known that mouth breathing increases upper-airway collapsibility during sleep and may contribute to the occurrence of sleep disordered breathing. In addition, it was shown that patients with a high percentage of mouth breathing during sleep were less adherent to CPAP therapy. Therefore, one potential solution to these problems is to use Varnum's mouthpiece to prevent mouth breathing during sleep.
The overall objective of the current study is to improve upper airway collapsibility and sleep apnea in OSA patients who have a high percentage of mouth breathing during sleep. The investigators' central hypothesis is that preventing the lips from parting with the Varnum device will reduce oral breathing and thereby OSA severity in mouth breathers. The investigators chose this hypothesis because "taping the mouth closed" with a simple device such as the Varnum mouthpiece is the most straightforward approach to dealing with this common problem. With this research, it could become possible to overcome one of the major problems contributing to sleep apnea - mouth breathing.
Therefore, the investigators aim to test the effect of the Varnum mouthpiece on pharyngeal collapsibility and OSA severity in patients who identify themselves as mouth breathers. The investigators' working hypothesis is that the device will keep the lips from separating and thereby prevent oral breathing. In doing so, it may help keep the airway more patent (by promoting nasal instead of oral breathing) in self-described mouth breathers and thus reduce OSA severity. On the contrary, the investigators believe patients who do not identify themselves as mouth breathers might not benefit significantly from the Varnum device.
The expected outcome of this study is validation of new device for improving sleep apnea in a large subgroup of easily identifiable OSA patients, namely self-described mouth breathers. Such a device could advance the field by providing more effective alternative treatments.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Polysomnogram With Varnum First, Regular Polysomnogram Second Varnum mouthpiece, similar to a mouth tape with central opening on the first night, then a 1-week non-treatment period, then overnight sleep study with no mouthpiece. |
Device: Varnum mouthpiece
An adhesive mouthpiece with a central opening applied during sleep
Other Names:
|
| Active Comparator: Regular Polysomnogram First, Polysomnogram With Varnum Second Baseline sleep study without Varnum mouthpiece on the first night, then a 1-week non-treatment period, then an overnight sleep study with Varnum mouthpiece on the second night. |
Device: Varnum mouthpiece
An adhesive mouthpiece with a central opening applied during sleep
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Sleep Apnea Severity as Measured by Apnea-hypopnea Index (AHI) [Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece]
The number of respiratory events (apneas and hypopneas) per hour of sleep. This was measured on two nights in random order (night with Varnum mouthpiece and night without Varnum mouthpiece). The median AHI on the night with Varnum mouthpiece was then compared with median AHI on the night without Varnum mouthpiece.
Secondary Outcome Measures
- Pharyngeal Collapsibility as Measured by Median Peak Inspiratory Flow During Sleep [Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece]
The median peak flow during sleep was measured and compared on both nights (night with Varnum mouthpiece and night without Varnum mouthpiece). The median peak flow is a surrogate measure of upper airway collapsibility.
- Snoring Index in Simple Snorers [Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece]
Snoring index is the number of breaths with snoring per hour of sleep. This was measured in both nights (night with Varnum mouthpiece and night without Varnum mouthpiece) only in simple snorers with AHI<10. The median of snoring index was compared between night with Varnum mouthpiece and night without Varnum mouthpiece.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Presence of obstructive sleep apnea (AHI>10 events/hr)
Exclusion Criteria:
-
Serious co-morbidities including lung disease, heart disease, renal disease
-
Medications affecting respiration or sleep
Mouth breather subgroup inclusion criteria: self-described mouth breathing habit during sleep.
non-mouth breathing subgroup inclusion criteria: absence of self-described mouth breathing during sleep
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sleep Disorders Research Program Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- David Andrew Wellman
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- 2012P000957F
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Polysomnogram With Varnum First, Regular Polysomnogram Second | Regular Polysomnogram First, Polysomnogram With Varnum Second |
|---|---|---|
| Arm/Group Description | Varnum mouthpiece, similar to a mouth tape with central opening on the first night, then a 1-week non-treatment period, then overnight sleep study with no mouthpiece. | Baseline sleep study without Varnum mouthpiece on the first night, then a 1-week non-treatment period, then an overnight sleep study with Varnum mouthpiece on the second night. |
| Period Title: Overall Study | ||
| STARTED | 11 | 15 |
| COMPLETED | 11 | 14 |
| NOT COMPLETED | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Polysomnogram With Varnum First, Regular Polysomnogram Second | Regular Polysomnogram First, Polysomnogram With Varnum Second | Total |
|---|---|---|---|
| Arm/Group Description | Varnum mouthpiece, similar to a mouth tape with central opening on the first night, then a 1-week non-treatment period, then overnight sleep study with no mouthpiece. | Baseline sleep study without Varnum mouthpiece on the first night, then a 1-week non-treatment period, then an overnight sleep study with Varnum mouthpiece on the second night. | Total of all reporting groups |
| Overall Participants | 11 | 15 | 26 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
54.2
(13.4)
|
55.3
(8.1)
|
54.8
(10.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
2
18.2%
|
9
60%
|
11
42.3%
|
| Male |
9
81.8%
|
6
40%
|
15
57.7%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
9.1%
|
0
0%
|
1
3.8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
3
27.3%
|
4
26.7%
|
7
26.9%
|
| White |
7
63.6%
|
11
73.3%
|
18
69.2%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
11
100%
|
15
100%
|
26
100%
|
| Apnea-Hypopnea Index (Events/hour) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Events/hour] |
17.0
(14.3)
|
25.5
(18.1)
|
21.9
(16.8)
|
| Snoring Index (Events/hour) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Events/hour] |
36.0
(57.9)
|
331.2
(271.7)
|
146.7
(215.3)
|
Outcome Measures
| Title | Sleep Apnea Severity as Measured by Apnea-hypopnea Index (AHI) |
|---|---|
| Description | The number of respiratory events (apneas and hypopneas) per hour of sleep. This was measured on two nights in random order (night with Varnum mouthpiece and night without Varnum mouthpiece). The median AHI on the night with Varnum mouthpiece was then compared with median AHI on the night without Varnum mouthpiece. |
| Time Frame | Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Polysomnogram With Varnum Mouthpiece | Regular Polysomnogram |
|---|---|---|
| Arm/Group Description | Varnum mouthpiece, similar to a mouth tape with central opening | Overnight sleep study without Varnum mouthpiece |
| Measure Participants | 25 | 25 |
| Median (Inter-Quartile Range) [Events/hour] |
16.4
|
15.8
|
| Title | Pharyngeal Collapsibility as Measured by Median Peak Inspiratory Flow During Sleep |
|---|---|
| Description | The median peak flow during sleep was measured and compared on both nights (night with Varnum mouthpiece and night without Varnum mouthpiece). The median peak flow is a surrogate measure of upper airway collapsibility. |
| Time Frame | Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Polysomnogram With Varnum Mouthpiece | Regular Polysomnogram |
|---|---|---|
| Arm/Group Description | Median peak flow from the night with Varnum mouthpiece | Median peak flow from the night without Varnum mouthpiece |
| Measure Participants | 25 | 25 |
| Median (Inter-Quartile Range) [L/s] |
0.32
|
0.36
|
| Title | Snoring Index in Simple Snorers |
|---|---|
| Description | Snoring index is the number of breaths with snoring per hour of sleep. This was measured in both nights (night with Varnum mouthpiece and night without Varnum mouthpiece) only in simple snorers with AHI<10. The median of snoring index was compared between night with Varnum mouthpiece and night without Varnum mouthpiece. |
| Time Frame | Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece |
Outcome Measure Data
| Analysis Population Description |
|---|
| This outcome was only calculated for simple snorers with AHI<10 events/hour. |
| Arm/Group Title | Polysomnogram With Varnum Mouthpiece | Regular Polysomnogram |
|---|---|---|
| Arm/Group Description | Number of snores per hour on the night with Varnum mouthpiece | Number of snores per hour on the night without Varnum |
| Measure Participants | 8 | 8 |
| Median (Inter-Quartile Range) [Snore/hour] |
3.0
|
30.4
|
Adverse Events
| Time Frame | 2 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Three types of adverse event data are reported, including "All-Cause Mortality," "Serious," and "Other (Not Including Serious)" Adverse Events. | |||
| Arm/Group Title | Polysomnogram With Varnum Mouthpiece | Regular Polysomnogram | ||
| Arm/Group Description | Varnum mouthpiece, similar to a mouth tape with central opening | Overnight sleep study without Varnum mouthpiece | ||
All Cause Mortality |
||||
| Polysomnogram With Varnum Mouthpiece | Regular Polysomnogram | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | 0/26 (0%) | ||
Serious Adverse Events |
||||
| Polysomnogram With Varnum Mouthpiece | Regular Polysomnogram | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | 0/26 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Polysomnogram With Varnum Mouthpiece | Regular Polysomnogram | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | 0/26 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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 | Andrew Wellman |
|---|---|
| Organization | Brigham and Women's Hospital |
| Phone | 6174078483 |
| awellman@rics.bwh.harvard.edu |
- 2012P000957F