Mandibular Advancement Device (MAD) therapy in edentulous patients with obstructive sleep apnea: dental implant fixed MADs vs. CPAP.
Withdrawn
- Conditions
- Obstructive sleep apnea syndromesleep apnea1004630410019190
- Registration Number
- NL-OMON45006
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- 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 mild or moderate OSA (AHI between 5 * 30)
- No previous OSA therapy
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
- Intravenous bisphosphonates therapy (osteoporosis).
- Previous radiotherapy in head and/or neck area
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