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Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance

NCT ID: NCT00152672

Last Updated: 2005-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Brief Summary

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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

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Conditions

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Sleep Apnea Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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nCPAP vs oral appliance

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Frédéric Gagnadoux

Role: PRINCIPAL_INVESTIGATOR

UH Angers

Locations

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CHU

Angers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Frédéric Gagnadoux, MD

Role: CONTACT

Phone: 33(0)241353695

Email: [email protected]

Facility Contacts

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Frédéric Gagnadoux, MD

Role: primary

Other Identifiers

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PHRC 04-10

Identifier Type: -

Identifier Source: org_study_id