Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance

This study is currently recruiting participants.

Verified by University Hospital, Angers, February 2005

First Received: September 8, 2005 Last Updated: October 27, 2005 History of Changes

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

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

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

No publications provided

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

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:

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

ClinicalTrials.gov processed this record on July 06, 2009