Predicting the success of mandibular advancement device therapy in obstructive sleep apnea

• Conditions: Obstructive sleep apneaObstructiefslaapapneuMandibular advancement device (MAD)Mandibulair repositie apparaat (MRA)

• Registration Number: NL-OMON22428
• Lead Sponsor: Amphia hospital, Breda, the Netherlands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 380

Inclusion Criteria

•18 years or older at time of inclusion

•Established OSA (AHI of 5/hour or more on poly(somno)graphy)

Exclusion Criteria

•patients with dental status hindering the use of MAD such as periodontal and dental problems, severe temporomandibular disorders. Patients with dental implants are allowed to participate.

•patients who cannot be properly instructed on the use of MAD, including patients with mental illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•decrease in AHI of at least 50% and AHI< 10/hour, OR<br /><br>•decrease in AHI below 5/hour if baseline AHI was < 10/hour

Secondary Outcome Measures

Name	Time	Method
Decrease in ESS questionnaire, adverse effects, therapy score (1-9), any change in AHI, FOSQ questionnaire, SF-36 questionnaire, compliance.