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NCT01426607 Clinical Trial

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

Obstructive Sleep Apnea Syndrome Clinical Trial

— VASO-AM  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01426607
Other study ID # PHRC 2010-06
Secondary ID
Status Completed
Phase N/A
First received June 28, 2011
Last updated December 12, 2016
Start date March 2011
Est. completion date March 2015

Study information
Verified date August 2011
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority France: Agence française de sécurité sanitaire des produits de santé (AFSSAPS)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Device:
• AMO

Locations
Country Name City State
France CHU Grenoble Grenoble
France CH Le Mans Le Mans
France Hopital Saint Antoine Paris
France CHU Poitiers Poitiers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary change from baseline to 2-months in reactive hyperemia index (RHI), a validated measurement of endothelial function. 2 months No
Secondary change from baseline to 2-months in markers of OSA severity 2 months No
Secondary change from baseline to 2-months in blood pressure 2 months No
Secondary change from baseline to 2-months in symptoms of OSA 2 months No
Secondary evaluate treatment compliance objectively measured by an embedded micro sensor 15 weeks No
See also
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