Management of the Obstructive Sleep Apnea-Hypopnea Syndrome: Oral Appliance versus Continuous Positive Airway Pressure Therapy.
Completed
- Conditions
- Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS).
- Registration Number
- NL-OMON22799
- Lead Sponsor
- Drs. A. HoekemaProf. Dr. B. StegengaProf. Dr. LGM de Bont Drs. A.F. MeineszDr. P.J. WijkstraDr. J.H. van der HoevenDr. M.F. van Driel
- Brief Summary
1. Sleep Breath. 2006 Jun;10(2):102-3. <br> <br><br> 2. Hoekema A, Stegenga B, de Bont LGM. Efficacy and Co-Morbidity of Oral Appliances in the Treatment of Obstructive Sleep Apnea-Hypopnea: a Systematic Review. Crit Rev Oral Biol Med 2004;15 (3):137-155.<br>
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 102
Inclusion Criteria
1. Newly diagnosed OSAHS patients (i.e. criterion A and/or B, plus criterion C):
a. Excessive daytime sleepiness that is not better explained by other factors (Epworth Sleepiness Scale ¡Ý 10).
Exclusion Criteria
I. Exclusioncriteria
1. Patients previously treated by:
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of OSAHS patients successfully treated as a result of OA or CPAP therapy.
- Secondary Outcome Measures
Name Time Method Improvements in:<br /><br>1. polysomnographic indices;<br /><br>2. neurobehavioral outcomes (e.g. SF-36, FOSQ, ESS, HADS);<br /><br>3. simulated driving performance;<br /><br>4. cardiovascular outcomes (e.g. BNP);<br /><br>5. sexual dysfunction (e.g. GRISS).