- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02738255
Effect of Added Varnum Mouthpiece on Pharyngeal Collapsibility and Sleep Apnea Severity in Mouth Breathers.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Sleep Disorders Research Program Brigham and Women's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
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An adhesive mouthpiece with a central opening applied during sleep
Other Names:
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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.
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An adhesive mouthpiece with a central opening applied during sleep
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Apnea Severity as Measured by Apnea-hypopnea Index (AHI)
Time Frame: 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.
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Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharyngeal Collapsibility as Measured by Median Peak Inspiratory Flow During Sleep
Time Frame: 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.
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Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece
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Snoring Index in Simple Snorers
Time Frame: 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.
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Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012P000957F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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