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

ONIRIS211 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

211

Conditions

Obstructive Sleep Apnea

Interventions

ONIRIS®DEVICE

sleeping test

TALIDEVICE

sleeping test

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Clinique Bel-Air

Bordeaux, France

Polyclinique Saint Privat

Boujan-sur-Libron, France

CHU de Grenoble

La Tronche, France

Hôpital André Mignot

Le Chesnay, France

Outcomes

Primary Outcomes

To evaluate the efficacity (non-inferiority) in terms of response between patients using mandibular advancement devices ONIRIS® and patient using devices produced in a laboratoryTALI after 2 months of use.

The response to the treatment is defined as: * complete patient response: AHI per hour of sleep \< 10 or * partial patient response: AHI per hour of sleep reduced by 50% at visit M2 compared to baseline

Time frame: 2 monthes of use

Secondary Outcomes

Evolution of AHI, AI and HI

AHI per hour of sleep with the same modalities as the one used for diagnosis (realised by ambulatory PG or PSG)

Time frame: at M2 and at M12

Percentage of patients responder

Percentage of patients responder at the last control exam

Time frame: at M2 and M12

Evolution during the study of the principal criteria concerning the sleep

Snoring measured by VAS, Epworth Sleepness Scale measuring daytime sleepness, Pichot Questionnaire measuring fatigue and depression

Time frame: at baseline, M2, M6 and M12

Evolution of the quality of life

Quality of life evaluated by SF12 at each visit

Time frame: at baseline, M2, M6 and M12

Evolution of the compliance

Percantage of compliance (excellent \> 85%, good \> 50%)

Time frame: at M2, M6 and M12

Evolution of tolerance

Nature, frequency and intensity of AE at each visit

Time frame: at M2, M6 and M12

Data from ClinicalTrials.gov

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