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Completed

NCT Number: NCT02738255

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

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.

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sleep Disorders Research Program Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varnum mouthpiece

Device

An adhesive mouthpiece with a central opening applied during sleep

Other names: Somnifix mouthpiece

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

David Andrew Wellman

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2016
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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