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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: TALI; Device: ONIRIS®

• Registration Number: NCT02348970
• Lead Sponsor: ONIRIS

Brief Summary

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

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

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-28
• Primary Completion: 2018-04-28
• Study Completion: 2018-04-28
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laboratory devices TALI	TALI	The patients will use the laboratory devices TALI
mandibular advancement devices ONIRIS®	ONIRIS®	The patients will use the mandibular advancement devices ONIRIS®

Primary Outcome Measures

Name	Time	Method
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.	2 monthes 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

Secondary Outcome Measures

Name	Time	Method
Evolution of tolerance	at M2, M6 and M12	Nature, frequency and intensity of AE at each visit
Evolution of the quality of life	at baseline, M2, M6 and M12	Quality of life evaluated by SF12 at each visit
AE and SAE occuring during the study	at M2, M6 and M12	Description and comparison at each group of AE and SAE
Evolution of AHI, AI and HI	at M2 and at M12	AHI per hour of sleep with the same modalities as the one used for diagnosis (realised by ambulatory PG or PSG)
Percentage of patients responder	at M2 and M12	Percentage of patients responder at the last control exam
Evolution during the study of the principal criteria concerning the sleep	at baseline, M2, M6 and M12	Snoring measured by VAS, Epworth Sleepness Scale measuring daytime sleepness, Pichot Questionnaire measuring fatigue and depression
Evolution of the compliance	at M2, M6 and M12	Percantage of compliance (excellent \> 85%, good \> 50%)
Evolution of arterial hypertension	at baseline, M2, M6 and M12	Arterial hypertension evaluated at each visit

Trial Locations

Locations (8)

CHU de Grenoble; 🇫🇷 La Tronche, France

Clinique Bel-Air; 🇫🇷 Bordeaux, France

Polyclinique Saint Privat; 🇫🇷 Boujan sur Libron, France

Hôpital André Mignot; 🇫🇷 Le Chesnay, France

CHU Montpellier; 🇫🇷 Montpellier, France

Medical Practice; 🇫🇷 Perpignan, France

Fondation Ophtalmologique Adolphe de Rothschild; 🇫🇷 Paris, France

Centre Cardiologique du Nord; 🇫🇷 St Denis, France