Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance - Tabular View

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Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance

This study is currently recruiting participants.

Study NCT00152672. Last updated on October 27, 2005. Information provided by University Hospital, Angers

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance

Official Title ^†

Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance: a Multicentre Prospective Randomized Crossover Trial

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.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Sleep Apnea Syndrome

Intervention ^†

Device: nCPAP vs oral appliance

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

June 2005

Completion Date

Eligibility 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

Gender

Male

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Frédéric Gagnadoux, MD

33(0)241353695

frgagnadoux@chu-angers.fr

Location Countries ^†

France

Administrative Information Fields

NCT ID ^†

NCT00152672

Organization ID

PHRC 04-10

Secondary IDs ^††

Study Sponsor ^†

University Hospital, Angers

Collaborators ^††

Investigators ^†

Principal Investigator:

Frédéric Gagnadoux

UH Angers

Information Provided By

University Hospital, Angers

Verification Date

February 2005

First Received Date ^†

September 8, 2005

Last Updated Date

October 27, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.