Predicting the success of mandibular repositioning appliance therapy in obstructive sleep apnea
- Conditions
- OSASsleep apnea10040998
- Registration Number
- NL-OMON48663
- Lead Sponsor
- Amphia Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 380
• 18 years or older at time of inclusion
• Established OSA (AHI of 5/hour or more on poly(somno)graphy)
• Symptomatic OSA (ESS-score > 10)
• patients with dental status hindering the use of MRA such as less than 10 teeth per dental arch, 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 MRA, including patients with mental illness
• presence of complete nasal obstruction
• presence of a tumour in the upper airways
• adenotonsillar hypertrophy grades 3 and 4
• body mass index > 40kg/m2
• presence of obesity hypoventilation syndrome
• presence of any neuromuscular disorder
• chronic obstructive lung disease (COPD) with documented hypercapnia
• central sleep apnea component of > 50% of total AHI
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>effective treatment with MRA is described as a reduction in AHI of at least 50%<br /><br>combined with an AHI< 10. If AHI at baseline was < 10, the index must decrease<br /><br>to at least < 5.</p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>