Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance - Tabular View

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

October 27, 2005

Start Date ^ICMJE

June 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00152672 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Sleep Apnea Syndrome

Intervention ^ICMJE

Device: nCPAP vs oral appliance

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Contact: Frédéric Gagnadoux, MD

33(0)241353695

frgagnadoux@chu-angers.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00152672

Responsible Party

Study ID Numbers ^ICMJE

PHRC 04-10

Study Sponsor ^ICMJE

University Hospital, Angers

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Frédéric Gagnadoux

UH Angers

Information Provided By

University Hospital, Angers

Verification Date

February 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP