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

University Hospital, Angers

Status: Completed

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Device: AMO

Study type: Interventional

Funder types: Other

Identifiers

NCT01426607

PHRC 2010-06

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups, including a placebo group

AMO

Experimental group

Description:

Adjustable mandibular repositioning appliance

Treatment:

Device: AMO

placebo

Placebo Comparator group

Description:

placebo device in upper jaw

Treatment:

Device: AMO