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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-04-28

Brief Summary

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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.

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Detailed Description

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

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mandibular advancement devices ONIRIS®

The patients will use the mandibular advancement devices ONIRIS®

Group Type EXPERIMENTAL

ONIRIS®

Intervention Type DEVICE

sleeping test

laboratory devices TALI

The patients will use the laboratory devices TALI

Group Type ACTIVE_COMPARATOR

TALI

Intervention Type DEVICE

sleeping test

Interventions

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ONIRIS®

sleeping test

Intervention Type DEVICE

TALI

sleeping test

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No