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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:
ClinicalTrials.gov Identifier:
NCT00152672
First Posted: September 9, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Angers
  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: None (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:


Further study details as provided by University Hospital, Angers:

Estimated Enrollment: 60
Study Start Date: June 2005
  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 8, 2005
First Posted: September 9, 2005
Last Update Posted: December 9, 2005
Last Verified: February 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