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

NCT02738255 | Completed Results

• 1 other identifier: 2012P000957F
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea; Mouth breathing; Apnea-Hypopnea Index (AHI)

Outcome Measures

Primary Outcomes (1)

• 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.

  Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece

Secondary Outcomes (2)

• Pharyngeal Collapsibility as Measured by Median Peak Inspiratory Flow During Sleep

  Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece

• Snoring Index in Simple Snorers

  Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece

Study Arms (2)

Polysomnogram With Varnum First, Regular Polysomnogram Second

ACTIVE COMPARATOR

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

Regular Polysomnogram First, Polysomnogram With Varnum Second

ACTIVE COMPARATOR

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

Interventions

Varnum mouthpiece DEVICE

An adhesive mouthpiece with a central opening applied during sleep

Also known as: Somnifix mouthpiece

Polysomnogram With Varnum First, Regular Polysomnogram Second; Regular Polysomnogram First, Polysomnogram With Varnum Second

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of obstructive sleep apnea (AHI\>10 events/hr)

You may not qualify if:

• Serious co-morbidities including lung disease, heart disease, renal disease
• Medications affecting respiration or sleep

Sponsors & Collaborators

• David Andrew Wellman: lead

Study Sites (1)

Sleep Disorders Research Program Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Mouth Breathing

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Andrew Wellman
• Organization: Brigham and Women's Hospital

awellman@rics.bwh.harvard.edu

6174078483

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 14, 2016
• Study Start: June 2, 2016
• Primary Completion: June 15, 2017
• Study Completion: June 15, 2017
• Last Updated: April 4, 2022
• Results First Posted: July 3, 2018

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)