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| Sponsored by: |
University Hospital, Angers |
|---|---|
| Information provided by: | University Hospital, Angers |
| ClinicalTrials.gov Identifier: | NCT00152672 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Sleep Apnea Syndrome |
Device: nCPAP vs oral appliance |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
| Official Title: | Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance: a Multicentre Prospective Randomized Crossover Trial |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Frédéric Gagnadoux, MD | 33(0)241353695 | frgagnadoux@chu-angers.fr |
| France | |
| CHU | Recruiting |
| Angers, France, 49033 | |
| Contact: Frédéric Gagnadoux, MD 33(0)241353695 frgagnadoux@chu-angers.fr | |
| Principal Investigator: Frédéric Gagnadoux, MD | |
| Principal Investigator: | Frédéric Gagnadoux | UH Angers |
More Information
| Study ID Numbers: | PHRC 04-10 |
| Study First Received: | September 8, 2005 |
| Last Updated: | October 27, 2005 |
| ClinicalTrials.gov Identifier: | NCT00152672 History of Changes |
| Health Authority: | France: French General Health Administration |
|
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
|
Sleep Apnea Syndromes Disease Apnea Respiration Disorders Nervous System Diseases Dyssomnias Sleep Disorders |
Sleep Disorders, Intrinsic Signs and Symptoms Pathologic Processes Respiratory Tract Diseases Syndrome Signs and Symptoms, Respiratory |