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A Study Comparing Two Mandibular Advancement Devices in the Treatment of Sleep Apnea
Sponsor: Ziekenhuis Oost-Limburg
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.
Official title: A Randomised, Controlled Cross Over Study Comparing Two Mandibular Advancement Devices in the Treatment of Mild-to-moderate Obstructive Sleep Apnea
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-03-20
Completion Date
2026-04-01
Last Updated
2025-03-21
Healthy Volunteers
No
Conditions
Interventions
Polygraphy
Polygraphy will be caried out at the patients home to evaluate each MRA after 3 monhts
Questionaire
Epworth Sleepiness Scale o Johns, Murray W. "A New Method for Measuring Daytime Sleepiness: The Epworth Sleepiness Scale." Sleep, vol. 14, no. 6, 1991, pp. 540-545.
Questionaire
Patient experience questionnaire o Ng, E.T., Perez-Garcia, A., en Lagravère-Vich, M.O. "Development and Initial Validation of a Questionnaire to Measure Patient Experience with Oral Appliance Therapy." Journal of Clinical Sleep Medicine, vol. 19, nr. 8, 1 aug. 2023, pp. 1437-1445. doi: 10.5664/jcsm.10562. PMID: 37082817; PMCID: PMC10394373
Question
Patient final choice of preferred MRA