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Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance

This study is currently recruiting participants.
Study NCT00152672.   Last updated on October 27, 2005.   Information provided by University Hospital, Angers

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Descriptive Information Fields
Brief Title  Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance
Official Title  Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance: a Multicentre Prospective Randomized Crossover Trial
Brief Summary

This prospective randomized cross over study aims to compare nCPAP with mandibular advancement device for the treatment of sleep apnea syndrome.The effectiveness of nCPAP and oral appliance on apnea-hypopnea index, daytime sleepiness and quality of life will be compared in 60 patients.

Detailed Description
Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Sleep Apnea Syndrome
Intervention  Device: nCPAP vs oral appliance
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  60
Start Date  June 2005
Completion Date
Eligibility Criteria 

Inclusion Criteria:

18 to 70 years old BMI < 35 kg/m2 Apnea-hypopnea index between 10 and 60 events/h Complaint of snoring and sleepiness Dental status adequate for treatment with oral appliance informed consent

Exclusion Criteria:

psychiatric disease professional driver other cause of sleepiness

Gender Male
Ages 18 Years to 70 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Frédéric Gagnadoux, MD     33(0)241353695     frgagnadoux@chu-angers.fr    
Location Countries  France
Administrative Information Fields
NCT ID  NCT00152672
Organization ID PHRC 04-10
Secondary IDs ††
Study Sponsor  University Hospital, Angers
Collaborators ††
Investigators 
Principal Investigator:     Frédéric Gagnadoux     UH Angers    
Information Provided By University Hospital, Angers
Verification Date February 2005
First Received Date  September 8, 2005
Last Updated Date October 27, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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