Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

Sponsor:

Information provided by:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT00152672

First received: September 8, 2005

Last updated: October 27, 2005

Last verified: February 2005

History of Changes

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 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 (Adult, Senior)
Sexes 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

Additional relevant MeSH terms:


Syndrome Apnea Sleep Apnea Syndromes Disease Pathologic Processes Respiration Disorders Respiratory Tract Diseases	Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases

ClinicalTrials.gov processed this record on June 26, 2017

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