Treatment of severe obstructive sleep apnea syndrome: evaluation of a therapy combining continuous positive airway pressure with an oral appliance: a pilot study
Recruiting
- Conditions
- 'obstructive sleep apnea syndrome' and 'sleep apnea'10046304
- Registration Number
- NL-OMON34972
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
severe OSAS (AHI >30)
Age > 20 years.
Exclusion Criteria
Medical and psychological exclusion:
1. Morphologic abnormalities of the upper airway
2. Endocrine dysfunction
3. Reported or documented severe cardiac- or pulmonary co-morbidity
4. Psychiatric disorders
Dental exclusion for Oral Appliance therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The feasibility for planning a main randomised controlled study to compare<br /><br>OA-CPAP with CPAP alone.<br /><br>Patient*s satisfaction to an OA-CPAP with a questionnaire.</p><br>
- Secondary Outcome Measures
Name Time Method <p>An ambulant polysomnography will be assessed for the AHI (efficacy), arousals,<br /><br>sleep stages and oxyhemoglobin saturation.<br /><br>Compliance is operationalized by assessing the number of hours per night and<br /><br>the number of nights per week that the device is used (questionnaire).<br /><br>Side-effects, EDS (excessive daytime sleepiness ) and neurobehavioral outcomes<br /><br>will also be evaluated with a questionnaire. </p><br>