RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mouth Tape for Snoring and Sleep Apnea (MTASSA)

Quick Facts

Study Start:2024-12-01
Study Completion:2029-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06587256

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  1. * Allergy to silicone mouth tape, chronic lung disease, facial hair preventing wearing of the tape
  2. * Grade 3+ or 4+ tonsils, prior palatal or tongue surgery.
  3. * Patients may not have any form of chronic or acute hypoventilation.
  4. * Patients must be able to tolerate breathing through their nose with the mouth tape in place for at least 3 minutes.
  5. * Patients may not be pregnant

Contacts and Locations

Study Contact

Mariah Potocki Study Coordinator
CONTACT
410-550-2233
mchaney7@jhmi.edu
Athena Mavronis
CONTACT
410-550-4588
amvaron1@jhmi.edu

Principal Investigator

Jonathan Jun, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Jonathan Jun, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-01
Study Completion Date2029-10

Study Record Updates

Study Start Date2024-12-01
Study Completion Date2029-10

Terms related to this study

Keywords Provided by Researchers

  • sleep apnea
  • snoring
  • mouth tape

Additional Relevant MeSH Terms

  • Mild Obstructive Sleep Apnea
  • Snoring