VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea Syndrome

• 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

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-06-28
• Status Verified: 2011-08
• Study First Submitted QC: 2011-08-30
• Study First Posted: 2011-08-31
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2016-12-12
• Last Update Posted: 2016-12-13

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

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)

CHU Grenoble; 🇫🇷 Grenoble, France

CH Le Mans; 🇫🇷 Le Mans, France

Hopital Saint Antoine; 🇫🇷 Paris, France

CHU Poitiers; 🇫🇷 Poitiers, France