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Effect of Added Varnum Mouthpiece on Pharyngeal Collapsibility and Sleep Apnea Severity in Mouth Breathers.

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ClinicalTrials.gov Identifier: NCT02738255
Recruitment Status : Completed
First Posted : April 14, 2016
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
David Andrew Wellman, Brigham and Women's Hospital

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
Obstructive Sleep Apnea Device: Varnum mouthpiece Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Added Varnum Mouthpiece on Pharyngeal Collapsibility and Sleep Apnea Severity in Mouth Breathers.
Actual Study Start Date : June 2, 2016
Actual Primary Completion Date : June 15, 2017
Actual Study Completion Date : June 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: Polysomnogram with Varnum Mouthpiece
Varnum mouthpiece, similar to a mouth tape with central opening
Device: Varnum mouthpiece
No Intervention: Regular Polysomnogram
Overnight sleep study with no mouthpiece



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738255


Locations
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United States, Massachusetts
Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
David Andrew Wellman
  Study Documents (Full-Text)

Documents provided by David Andrew Wellman, Brigham and Women's Hospital:
Study Protocol  [PDF] February 1, 2017
Statistical Analysis Plan  [PDF] February 1, 2017


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Responsible Party: David Andrew Wellman, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02738255     History of Changes
Other Study ID Numbers: 2012P000957F
First Posted: April 14, 2016    Key Record Dates
Results First Posted: July 3, 2018
Last Update Posted: July 3, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by David Andrew Wellman, Brigham and Women's Hospital:
Obstructive sleep apnea
Mouth breathing
Apnea-Hypopnea Index (AHI)

Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases