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Completed NCT06810479

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

Conditions: Apnea, Obstructive

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 16
Sponsor: Ziekenhuis Oost-Limburg

Location: Ziekenhuis Oost-Limburg Genk

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06810479). StuddyBuddy aggregates publicly available trial information.