Back to resultsTreatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance
Primary Purpose
Sleep Apnea Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
nCPAP vs oral appliance
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea Syndrome
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
Sites / Locations
- CHURecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00152672
First Posted
September 8, 2005
Last Updated
October 27, 2005
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT00152672
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2005
Overall Recruitment Status
Unknown status
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Angers
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
nCPAP vs oral appliance
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frédéric Gagnadoux, MD
Phone
33(0)241353695
Email
frgagnadoux@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Gagnadoux
Organizational Affiliation
UH Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Angers
ZIP/Postal Code
49033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Gagnadoux, MD
Phone
33(0)241353695
Email
frgagnadoux@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Frédéric Gagnadoux, MD
12. IPD Sharing Statement
Learn more about this trial
Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance
We'll reach out to this number within 24 hrs