Mandibular Advancement vs Home Treatment for Primary Snoring (NCT05756647) | Clinical Trial Compass
CompletedPhase 2
Mandibular Advancement vs Home Treatment for Primary Snoring
United States100 participantsStarted 2022-11-07
Plain-language summary
This is a randomized controlled trial for non-apneic snorers. The primary goal of the study is to evaluate the efficacy of a mandibular advancement device (MAD) vs conservative treatment for adults with non-apneic snoring as measured by the partners report of response to treatment (CGI-I). The secondary goal is to evaluate the effectiveness of treatment of snoring on the Epworth Sleepiness Scale (ESS), a modified Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) questionnaire, the Pittsburgh Sleep Quality Index (PSQI), and the Clinical Global Impression of Severity Scale (CGI-S)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18
* Report of snoring
* Prior polysomnogram (PSG) within the past 60 months showing AHI (Apnea Hypopnea Index) \< 5 and no more than 10% gain in body weight since the prior polysomnogram OR reasonable clinical suspicion that the participant does not have sleep apnea \[Reasonable Clinical Suspicion is defined as: BMI \<35, Neck circumference \<16.5 inches, lack of uncontrolled hypertension, no witnessed episodes of apnea, or multiple sleep studies in the past all showing lack of sleep apnea but with \>5 years since the most recent one.\]
* Possess a sleeping partner who sleeps in the same room as the participant for \>= 4 nights a week and who can report outcomes
* Access to the internet
* Ability to follow up within 1 month after adequate fitting of MAD or 4 weeks of Mometasone
Inclusion criteria for the sleeping partner:
* Age ≥ 18
* Possess a sleeping partner who sleeps in the same room as the participant for \>= 4 nights a week and who can report outcomes
* Access to the internet
Exclusion Criteria:
Individuals will not be allowed to participate in this study if they meet one or more of the exclusion criteria:
* Significant hypoxemia as defined as SaO2 (oxygen saturation) below 89% for ≥ 12% of the total nocturnal monitoring time
* Inability to wear a MAD defined as missing more than 50% of their dentition or their dentition is not in good condition.
* Prior intolerance of MAD
* Current treatment for OSA
* Concurrent use of sedatives or \…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Responders of Clinical Global Impression of Improvement Scale - Partner