VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea
Not Applicable
Completed
- Conditions
- Obstructive Sleep Apnea Syndrome
- Interventions
- Device: AMO
- Registration Number
- NCT01426607
- Lead Sponsor
- University Hospital, Angers
- Brief Summary
This is a randomized controlled study evaluating the impact of 2 months of oral appliance therapy on endothelial function in patients with severe obstructive sleep apnea syndrome intolerant to continuous positive airway pressure (CPAP) therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- AHI > 30
- Intolerance to CPAP therapy
- Signed informed consent
Exclusion Criteria
- Epworth sleepiness scale > 16/24
- Severe cardiac and/or respiratory disease
- BMI>32 kg/m2
- Dental contraindication to oral appliance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AMO AMO Adjustable mandibular repositioning appliance placebo AMO placebo device in upper jaw
- Primary Outcome Measures
Name Time Method change from baseline to 2-months in reactive hyperemia index (RHI), a validated measurement of endothelial function. 2 months
- Secondary Outcome Measures
Name Time Method change from baseline to 2-months in markers of OSA severity 2 months change from baseline to 2-months in blood pressure 2 months change from baseline to 2-months in symptoms of OSA 2 months evaluate treatment compliance objectively measured by an embedded micro sensor 15 weeks
Trial Locations
- Locations (4)
Hopital Saint Antoine
🇫🇷Paris, France
CHU Grenoble
🇫🇷Grenoble, France
CH Le Mans
🇫🇷Le Mans, France
CHU Poitiers
🇫🇷Poitiers, France