Sleep Apnea SyndromeNCT00152672
Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance
A study testing nCPAP vs oral appliance in people with Sleep Apnea Syndrome, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Sleep Apnea Syndrome
- What is being tested?
- nCPAP vs oral appliance
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2005to not given
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- psychiatric disease professional driver other cause of sleepiness
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU
Angers, 49033
Frédéric Gagnadoux, MD, 33(0)241353695, frgagnadoux@chu-angers.fr
Frédéric Gagnadoux, MD
About this study
Official title: Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance: a Multicentre Prospective Randomized Crossover Trial
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.
- Conditions
- Sleep Apnea Syndrome
- Being tested
- nCPAP vs oral appliance
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nCPAP vs oral applianceDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- Frédéric Gagnadoux, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152672
- Sponsor's protocol ID
- PHRC 04-10
- Status last verified
- Feb 2005
- First submitted
- 8 Sep 2005
- Last updated
- 28 Oct 2005
- Results posted
- No