Not Yet RecruitingNot Applicable

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

20 participantsStarted 2025-03-20

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 range18 Years

SexALL

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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

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 completion2026-01-31

Contact for this trial

Joeri Meyns, MD, DDS

+3289 32 50 50 joeri.meyns@zol.be

View on ClinicalTrials.gov More Apnea, Obstructive trials