Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2005 by University Hospital, Angers. Recruitment status was Recruiting

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

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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

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

Additional relevant MeSH terms:

Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory

Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012