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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Varnum mouthpiece
Sponsored by
David Andrew Wellman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, Mouth breathing, Apnea-Hypopnea Index (AHI)

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sleep Disorders Research Program Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Polysomnogram With Varnum First, Regular Polysomnogram Second

Regular Polysomnogram First, Polysomnogram With Varnum Second

Arm 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.

Outcomes

Primary Outcome Measures

Sleep Apnea Severity as Measured by Apnea-hypopnea Index (AHI)
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
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
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.

Full Information

First Posted
April 12, 2016
Last Updated
March 30, 2022
Sponsor
David Andrew Wellman
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1. Study Identification

Unique Protocol Identification Number
NCT02738255
Brief Title
Effect of Added Varnum Mouthpiece on Pharyngeal Collapsibility and Sleep Apnea Severity in Mouth Breathers.
Official Title
Effect of Added Varnum Mouthpiece on Pharyngeal Collapsibility and Sleep Apnea Severity in Mouth Breathers.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 2, 2016 (Actual)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
June 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Andrew Wellman

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea, Mouth breathing, Apnea-Hypopnea Index (AHI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polysomnogram With Varnum First, Regular Polysomnogram Second
Arm Type
Active Comparator
Arm 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.
Arm Title
Regular Polysomnogram First, Polysomnogram With Varnum Second
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Varnum mouthpiece
Other Intervention Name(s)
Somnifix mouthpiece
Intervention Description
An adhesive mouthpiece with a central opening applied during sleep
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Sleep Disorders Research Program Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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