NCT06587256 Study to Examine the Effect of Silicone Mouth Tape on Snoring and Mild Sleep Apnea.
| NCT ID | NCT06587256 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Johns Hopkins University |
| Condition | Mild Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2027-03-01 |
| Primary Completion | 2030-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2027-03-01 with a primary completion date of 2030-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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
Contact & Investigator
Jonathan Jun, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT06587256 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Mild Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06587256 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06587256 currently recruiting?
Yes, NCT06587256 is actively recruiting participants. Contact the research team at mchaney7@jhmi.edu for enrollment information.
Where is the NCT06587256 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06587256 clinical trial?
NCT06587256 is sponsored by Johns Hopkins University. The principal investigator is Jonathan Jun, MD at Johns Hopkins University. The trial plans to enroll 100 participants.