Efficacy and Compliance of the Mandibular Advancement Devices ONIRIS® vs. Custom Made Devices

ONIRIS

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: ONIRIS®; Device: TALI

Study type: Interventional

Funder types: Industry

Identifiers

NCT02348970

ONI-003

Details and patient eligibility

About

To evaluate the efficacy (non-inferiority) in terms of response between patients using custom fitted mandibular advancement devices ONIRIS® and patient using laboratory custom made devices TALI, after 2 months of use. Sleeping tests were performed.

Full description

Open, non-inferiority, controlled and rndomised clinical trial. Six months of inclusion. Each included patient will be followed during 12 months.

Enrollment: 211 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with severe syndrome of obstructive sleep apnea and hypopneas refusing or withdrawal from continuous positive pression ventilation
• no dental, paro-dental or articular contraindication
• patients never treated by mandibular advancement devices

Exclusion criteria

• severe psychiatric or neuromuscular disorders appreciated by the investigator
• more than 20% of apneas and central hypoapneas
• severe syndrome of obstructive sleep apnea and hypopneas with IAH > 30% associated with another sleeping pathology
• BMI > 30kg/m2
• patient with an uncontrollable nausea reflex
• epileptic patients
• pregnant patients
• patient without written informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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211 participants in 2 patient groups

mandibular advancement devices ONIRIS®

Experimental group

Description:

The patients will use the mandibular advancement devices ONIRIS®

Treatment:

Device: ONIRIS®

laboratory devices TALI

Active Comparator group

Description:

The patients will use the laboratory devices TALI

Treatment:

Device: TALI