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NCT00152672 Clinical Trial

Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance

Sleep Apnea Syndrome Clinical Trial

Official title:
Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance: a Multicentre Prospective Randomized Crossover Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00152672
Other study ID # PHRC 04-10
Secondary ID
Status Recruiting
Phase N/A
First received September 8, 2005
Last updated October 27, 2005
Start date June 2005

Study information
Verified date February 2005
Source University Hospital, Angers
Contact Frédéric Gagnadoux, MD
Phone 33(0)241353695
Email frgagnadoux@chu-angers.fr
Is FDA regulated No
Health authority France: French General Health Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• nCPAP vs oral appliance

Locations
Country Name City State
France CHU Angers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

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