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

NCT06810479 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-08-11

No results posted yet for this study

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.

Conditions

  • Apnea, Obstructive

Interventions

DIAGNOSTIC_TEST

Polygraphy

Polygraphy after 3 months of use of each appliance: an unattended home sleep study at the end of the first treatment period, and in-hospital polygraphy at the end of the second treatment period.

OTHER

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.

OTHER

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

OTHER

Question

Patient final choice of preferred MRA

Sponsors & Collaborators

  • Ziekenhuis Oost-Limburg

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-21
Primary Completion
2026-03-06
Completion
2026-03-06

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06810479 on ClinicalTrials.gov