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

Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance

This study is currently recruiting participants.
Verified by University Hospital, Angers, February 2005

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

MedlinePlus related topics:

Sleep Apnea

U.S. FDA Resources

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

Further study details as provided by University Hospital, Angers:

Estimated Enrollment:	60
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152672

Contacts


Contact: Frédéric Gagnadoux, MD	33(0)241353695	frgagnadoux@chu-angers.fr

Locations


France
	CHU	Recruiting
	Angers, France, 49033
	Contact: Frédéric Gagnadoux, MD 33(0)241353695 frgagnadoux@chu-angers.fr
	Principal Investigator: Frédéric Gagnadoux, MD

Sponsors and Collaborators

University Hospital, Angers

Investigators


Principal Investigator:	Frédéric Gagnadoux	UH Angers

More Information

Study ID Numbers:	PHRC 04-10
First Received:	September 8, 2005
Last Updated:	October 27, 2005
ClinicalTrials.gov Identifier:	NCT00152672
Health Authority:	France: French General Health Administration

Study placed in the following topic categories:

Signs and Symptoms

Sleep Apnea Syndromes

Respiratory Tract Diseases

Apnea

Respiration Disorders

Dyssomnias

Sleep Disorders

Signs and Symptoms, Respiratory

Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

Nervous System Diseases

ClinicalTrials.gov processed this record on September 05, 2008