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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
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
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 May 21, 2013