Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance
Sponsor
University Hospital, Angers (Other)
Overall Status
Unknown status
CT.gov ID
NCT00152672
Collaborator
(none)
60
1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance: a Multicentre Prospective Randomized Crossover Trial
Study Start Date
:
Jun 1, 2005
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes 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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU | Angers | France | 49033 |
Sponsors and Collaborators
- University Hospital, Angers
Investigators
- Principal Investigator: Frédéric Gagnadoux, UH Angers
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00152672
Other Study ID Numbers:
- PHRC 04-10
First Posted:
Sep 9, 2005
Last Update Posted:
Oct 28, 2005
Last Verified:
Feb 1, 2005