Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06587256

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

Led by Johns Hopkins University · Updated on 2025-11-28

100

Participants Needed

1

Research Sites

174 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 75 years
  • Body mass index of 35 kg/m2 or less
  • Self-reported history of snoring
  • Have a bed partner who can provide information about the snoring
  • Prior sleep study showing no sleep apnea or mild sleep apnea (AHI under 15 events/hour)
Not Eligible

You will not qualify if you...

  • Allergy to silicone mouth tape
  • Chronic lung disease
  • Facial hair that prevents wearing the mouth tape
  • Grade 3+ or 4+ tonsils
  • Prior palatal or tongue surgery
  • Any form of chronic or acute hypoventilation
  • Unable to tolerate nasal breathing with the mouth tape for at least 3 minutes
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States, 21224

Actively Recruiting

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Research Team

M

Mariah Potocki Study Coordinator

CONTACT

A

Athena Mavronis

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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