Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance

U

University Hospital, Angers

Status

Unknown

Conditions

Sleep Apnea Syndrome

Treatments

Device: nCPAP vs oral appliance

Study type

Interventional

Funder types

Other

Identifiers

NCT00152672
PHRC 04-10

Details and patient eligibility

About

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.

Sex

Male

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Frédéric Gagnadoux, MD

Data sourced from clinicaltrials.gov

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