CompletedNot Applicable

A Study Comparing Two Mandibular Advancement Devices in the Treatment of Sleep Apnea

Belgium16 participantsStarted 2025-03-21

Plain-language summary

The goal of this randomised, controlled cross-over study is to compare two mandibular repositioning devices (MRA) already on the market in the treatment of mild-to-moderate obstructive sleep apnea. Patiënt will test the first MRA for 3 months, after a wash out period of 2 weeks they will test the second MRA for 3 months. It will be randomised what type of MRA will be tested first and second.

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.

In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Provide signed and dated informed consent * Males or females aged 18 and above * Apnea-Hypopnea Index (AHI) between 5 and 30 events per hour diagnosed by a polysomnography A potential subject who meets any of the following criteria will be excluded from participation in this study: * Previous surgery on the upper airways * Prior treatment of OSA (CPAP or MRA) * Presence of unstable cardiovascular conditions, neurological, mental, or psychiatric disorders * Insufficient dental or periodontal condition for a mandibular repositioning appliance (MRA) * Presence of temporomandibular joint dysfunction

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

AHI

Timeframe: 3 monthts after use of first MRA (mandibular advancement device), 3 months after use of second MRA (mandibular advancement device)

Trial details

NCT IDNCT06810479

SponsorZiekenhuis Oost-Limburg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-06

View on ClinicalTrials.gov More Apnea, Obstructive trials