Mandibular advancement device (MAD) therapy in edentulous patients with obstructive sleep apnea: dental implant retained MAD therapy
Recruiting
- Conditions
- Obstructive sleep apnea syndromesleep apnea1004630410019190
- Registration Number
- NL-OMON47940
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 38
Inclusion Criteria
Male of female - Age 18 - 75 years - Sufficient understanding of Dutch language
in speaking and writing. - Completely (mandibular and maxillary) edentate with
or without dental implants - Diagnosed with moderate OSA (AHI between 15 - 30)
or unsuccessfully treated with CPAP with moderate or severe OSA (AHI > 15) - No
previous OSA therapy, except CPAP
Exclusion Criteria
Craniofacial deformities - Medication use related to a sleeping disorder -
Evidence of respiratory/sleep disorders other than OSA (eg. central sleep apnea
syndrome). - Reversible morphological upper airway abnormalities (e.g. enlarged
tonsils). - Temporomandibular disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>AHI (baseline vs. 3 months): apnea hypopnea Index (AHI) derived from<br /><br>standardized polysomnography studies at baseline and 3 months after CPAP<br /><br>treatment initiation (control-group) or MAD therapy initiation (intervention<br /><br>group).</p><br>
- Secondary Outcome Measures
Name Time Method