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Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance

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ClinicalTrials.gov Identifier: NCT00152672
Recruitment Status : Unknown
Verified February 2005 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : September 9, 2005
Last Update Posted : October 28, 2005
Sponsor:
Information provided by:
University Hospital, Angers

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Sleep Apnea Syndrome Device: nCPAP vs oral appliance Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
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
Study Start Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00152672     History of Changes
Other Study ID Numbers: PHRC 04-10
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: October 28, 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