NCT00152672

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
Last Updated

October 28, 2005

Status Verified

February 1, 2005

First QC Date

September 8, 2005

Last Update Submit

October 27, 2005

Conditions

Sleep Apnea Syndrome

Interventions

nCPAP vs oral applianceDEVICE

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • psychiatric disease professional driver other cause of sleepiness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU

Angers, 49033, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Frédéric Gagnadoux

    UH Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric Gagnadoux, MD

CONTACT

33(0)241353695frgagnadoux@chu-angers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

June 1, 2005

Last Updated

October 28, 2005

Record last verified: 2005-02

Locations

FR(1)