Study to Examine the Effect of Silicone Mouth Tape on Snoring and Mild Sleep Apnea.

NCT06587256 | Recruiting Phase 2

• 1 other identifier: IRB00425791
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Snoring is a common problem caused by vibration of tissues in the throat region during sleep. Although snoring is sometimes dismissed as a minor nuisance rather than a medical disorder, several studies indicate that snoring can disrupt sleep quality of the snorer, as well as the snorer's bed partner. Snoring also might lead to problems such as dry mouth, bad breath, dental problems, and even cardiovascular disease. Current treatments for snoring include lifestyle modifications such as weight loss, side-sleeping, and avoidance of evening alcohol intake. In some cases, invasive surgeries, dental devices, or even CPAP are recommended for snoring. These interventions have mixed effectiveness and may be difficult to use. It may be possible to treat snoring by fostering nasal breathing, while avoiding mouth-breathing during sleep. Breathing through the mouth reduces the airway diameter and contributes to snoring. Several studies show that nasal breathing can reduce snoring volume and improve airflow. Recent studies have shown that covering the mouth during sleep with adhesive patches or tape can improve snoring volume without adverse effects. However, these studies were performed in a small number of patients and did not fully measure the impact of the intervention on sleep quality, sleep architecture, or the experience of the bed partner, who is often the overlooked "victim" of the snoring. In this interventional study, the investigators will examine the safety and efficacy of mouth tape for snoring, focusing on subjective and objective snoring/breathing metrics of both the snorer and bed partner. Snoring is sometimes also a sign of obstructive sleep apnea (OSA). If OSA is ruled out with a sleep study, patients are considered to have "simple" snoring. When OSA is mild (apnea hypopnea index 15), treatments can include the same interventions as snoring (e.g. weight loss, avoidance of alcohol, side-sleeping) or can be more aggressively treated with devices such as continuous positive airway pressure (CPAP). CPAP may be challenging to use, expensive, and associated with side effects such as mouth dryness and skin irritation. Alternative, inexpensive, and well-tolerated interventions are needed for mild OSA. For this reason, the investigators include patients with snoring and mild OSA in this study.

Conditions

Mild Obstructive Sleep Apnea; Snoring

Keywords

sleep apnea; snoring; mouth tape

Outcome Measures

Primary Outcomes (1)

• Snoring / Sleep Survey (SSS)

  The patient will be asked about perceived snoring and sleep quality (score range 0-25, best=0, worst =25)

  Baseline and 3 months

Secondary Outcomes (7)

• Adherence and tolerance questionnaire

  3 months

• Sleep apnea severity (WatchPAT)

  Baseline and 3 months

• Snoring intensity (WatchPAT)

  Baseline and 3 months

• PROMIS Sleep Related Disturbance (SD) Short Form 8A (PROMIS-SD-8A)

  Baseline, 2 weeks, and 3 months

• PROMIS Sleep Related Impairment (SRI) Short Form 8A (PROMIS-SRI-8A)

  2 weeks

Study Arms (1)

Simple snorers or Mild Sleep Apnea

EXPERIMENTAL

Patients with snoring and a prior sleep study showing an AHI \< 15.

Device: Mouth Tape

Interventions

Mouth Tape DEVICE

A single piece of silicone tape placed vertically over the lips. When positioned properly the participant can still inhale/exhale and cough around the tape if needed, but will tend to keep mouth closed otherwise.

Simple snorers or Mild Sleep Apnea

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with a body mass index of 35 kg/m2 with a self-reported history of snoring and a bed partner who can provider answers to about the patients snoring. Patients must have a prior sleep study that shows no sleep apnea, or mild sleep apnea (AHI under 15 events/hr).

You may not qualify if:

• Allergy to silicone mouth tape, chronic lung disease, facial hair preventing wearing of the tape
• Grade 3+ or 4+ tonsils, prior palatal or tongue surgery.
• Patients may not have any form of chronic or acute hypoventilation.
• Patients must be able to tolerate breathing through their nose with the mouth tape in place for at least 3 minutes.
• Patients may not be pregnant

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

Related Publications (2)

• Lee YC, Lu CT, Cheng WN, Li HY. The Impact of Mouth-Taping in Mouth-Breathers with Mild Obstructive Sleep Apnea: A Preliminary Study. Healthcare (Basel). 2022 Sep 13;10(9):1755. doi: 10.3390/healthcare10091755.

  PMID: 36141367 BACKGROUND

• Huang TW, Young TH. Novel porous oral patches for patients with mild obstructive sleep apnea and mouth breathing: a pilot study. Otolaryngol Head Neck Surg. 2015 Feb;152(2):369-73. doi: 10.1177/0194599814559383. Epub 2014 Dec 1.

  PMID: 25450408 BACKGROUND

MeSH Terms

Conditions

Snoring; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Study Officials

• Jonathan Jun, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariah Potocki Study Coordinator

CONTACT

410-550-2233; mchaney7@jhmi.edu

Athena Mavronis

CONTACT

410-550-4588; amvaron1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm, open-label, non-randomized interventional clinical trial comparing each participant's baseline snoring or sleep apnea level to the participant's 3-month snoring or sleep apnea while using mouth tape during sleep.

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The individual participant data (IPD) will be available at the termination of the study and accessible for 2 years after study closure.
• Access Criteria: Requests must be provided to the P.I. in writing with documentation supporting the need for access. If appropriate a de-identified data set will be provided via an encrypted file.

Locations

US (1)