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