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

University Hospital, Angers150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

150

Conditions

Obstructive Sleep Apnea Syndrome

Interventions

AMODEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (4)

CHU Grenoble

Grenoble, France

CH Le Mans

Le Mans, France

Hopital Saint Antoine

Paris, France

CHU Poitiers

Poitiers, France

Outcomes

Primary Outcomes

change from baseline to 2-months in reactive hyperemia index (RHI), a validated measurement of endothelial function.

Time frame: 2 months

Secondary Outcomes

change from baseline to 2-months in markers of OSA severity

Time frame: 2 months

change from baseline to 2-months in blood pressure

Time frame: 2 months

change from baseline to 2-months in symptoms of OSA

Time frame: 2 months

evaluate treatment compliance objectively measured by an embedded micro sensor

Time frame: 15 weeks

Data from ClinicalTrials.gov

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