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

Recruiting now · Phase 2

Conditions studied: Mild Obstructive Sleep Apnea, Snoring

In brief

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.

Key facts

Study ID

NCT06587256

Run by

Johns Hopkins University

People needed

100

Starts

2027-03-01

Expected to finish

2030-10-01

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.