Status:
COMPLETED
Oral Appliance Therapy in Obstructive Sleep Apnea
Lead Sponsor:
VU University of Amsterdam
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the study was to compare the effects of a mandibular advancement device (MAD) with those of nasal continuous positive airway pressure(nCPAP) and of an intra-oral placebo device in obstructi...
Detailed Description
Setting and participants: Eligible OSA patients, living in the greater Amsterdam area, were referred to the Slotervaart Medical Center by their family physician. All patients underwent a thorough med...
Eligibility Criteria
Inclusion
- age \> 18 years
- apnea-hypopnea index (AHI) between 5 and 45 events per hour
Exclusion
- evidence of respiratory/ sleep disorders other than obstructive sleep apnea
- a body mass index (BMI) \> 40
- medication usage that could influence respiration or sleep
- periodic limb movement disorder
- previous treatment with CPAP or MAD
- reversible morphological upper airway abnormalities (e.g., enlarged tonsils)
- temporomandibular disorders (based on a functional examination of the masticatory system)
- untreated periodontal problems
- dental pain
- lack of retention possibilities for a mandibular advancement device or a placebo appliance
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00950495
Start Date
October 1 2003
End Date
July 1 2009
Last Update
December 25 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Academic Centre for Dentistry Amsterdam (ACTA), Research Institute Move, University of Amsterdam and VU University Amsterdam
Amsterdam, Netherlands, 1066 EA