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Behavioural Intervention

Mouth Tape for Snoring and Sleep Apnea (MTASSA Trial)

Phase 2
Recruiting
Led By Jonathan Jun, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a prior sleep study that shows no sleep apnea, or mild sleep apnea (AHI under 15 events/hr)
Be older than 18 years old
Must not have
Grade 3+ or 4+ tonsils, prior palatal or tongue surgery
Patients with any form of chronic or acute hypoventilation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, and 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at a new way to treat snoring by promoting nasal breathing instead of mouth breathing during sleep. Snoring can disrupt sleep quality for both the snorer and their bed partner, and

Who is the study for?
This trial is for individuals who snore or have mild sleep apnea, which hasn't been resolved by lifestyle changes or other treatments. Participants should not be using CPAP machines or have conditions that might interfere with the study.
What is being tested?
The study tests if mouth tape can help reduce snoring and improve sleep quality in people with mild sleep apnea. It will measure the effects on both the person who snores and their bed partner's experience.
What are the potential side effects?
Previous small studies suggest using mouth tape to encourage nasal breathing during sleep has no adverse effects. However, potential side effects may include skin irritation around the mouth or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had a sleep study showing I either don't have sleep apnea or it's mild.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had surgery on my tonsils, palate, or tongue.
Select...
I have chronic or acute breathing problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, and 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Snoring / Sleep Survey (SSS)
Secondary study objectives
Adherence and tolerance questionnaire
PROMIS Sleep Related Disturbance (SD) Short Form 8A (PROMIS-SD-8A)
PROMIS Sleep Related Impairment (SRI) Short Form 8A (PROMIS-SRI-8A)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Simple snorers or Mild Sleep ApneaExperimental Treatment1 Intervention
Patients with snoring and a prior sleep study showing an AHI \< 15.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,328 Previous Clinical Trials
14,874,525 Total Patients Enrolled
4 Trials studying Snoring
68 Patients Enrolled for Snoring
Jonathan Jun, MDPrincipal InvestigatorJohns Hopkins University
6 Previous Clinical Trials
216 Total Patients Enrolled
~67 spots leftby Oct 2029
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