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

Study Overview
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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.

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.

Official Title
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Multicenters, Randomised Clinical Trial, to Evaluate Efficacy and Compliance of Mandibular Advancement Devices ONIRIS® vs. Laboratory Devices TALI in Patients With Syndrome of Obstructive Sleep Apnea and Hypopneas

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: ONIRIS®
* Device: TALI


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mandibular advancement devices ONIRIS®<br>The patients will use the mandibular advancement devices ONIRIS® | Device: ONIRIS®<br>* sleeping test<br>|
| Active Comparator: laboratory devices TALI<br>The patients will use the laboratory devices TALI | Device: TALI<br>* sleeping test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 monthes of use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | at M2 and at M12 | 
| Percentage of patients responder | Percentage of patients responder at the last control exam | 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 | at baseline, M2, M6 and M12 | 
| Evolution of the quality of life | Quality of life evaluated by SF12 at each visit | at baseline, M2, M6 and M12 | 
| Evolution of the compliance | Percantage of compliance (excellent > 85%, good > 50%) | at M2, M6 and M12 | 
| Evolution of tolerance | Nature, frequency and intensity of AE at each visit | at M2, M6 and M12 | 
| AE and SAE occuring during the study | Description and comparison at each group of AE and SAE | at M2, M6 and M12 | 
| Evolution of arterial hypertension | Arterial hypertension evaluated at each visit | at baseline, M2, M6 and M12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mandibular advancement devices ONIRIS®, obstructive sleep apnea and hypopneas