Clinical trial NCT02348970: Efficacy and Compliance of the Mandibular Advancement Devices ONIRIS® vs. Custom Made Devices
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: mandibular advancement devices ONIRIS®
obstructive sleep apnea and hypopneas
Lead sponsor: ONIRIS
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 2 monthes of use
Secondary outcomes:
measure: Evolution of AHI, AI and HI
timeFrame: at M2 and at M12
measure: Percentage of patients responder
timeFrame: at M2 and M12
measure: Evolution during the study of the principal criteria concerning the sleep
timeFrame: at baseline, M2, M6 and M12
measure: Evolution of the quality of life
timeFrame: at baseline, M2, M6 and M12
measure: Evolution of the compliance
timeFrame: at M2, M6 and M12
measure: Evolution of tolerance
timeFrame: at M2, M6 and M12
measure: AE and SAE occuring during the study
timeFrame: at M2, M6 and M12
measure: Evolution of arterial hypertension
timeFrame: at baseline, M2, M6 and M12
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinique Bel-Air
city: Boujan sur Libron
country: France
facility: Polyclinique Saint Privat
city: La Tronche
country: France
facility: CHU de Grenoble
city: Le Chesnay
country: France
facility: Hôpital André Mignot
city: Les Pavillons sous Bois
country: France
facility: Medical Practice
city: Maisons-Alfort
country: France
facility: Medical Practice
city: Montpellier
country: France
facility: CHU Montpellier
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Perpignan
country: France
facility: Medical Practice
city: St Denis
country: France
facility: Centre Cardiologique du Nord
Study officials:
affiliation: Hôpital Bel Air
name: RAYMOND Nathalie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pepin JL, Raymond N, Lacaze O, Aisenberg N, Forcioli J, Bonte E, Bourdin A, Launois S, Tamisier R, Molinari N. Heat-moulded versus custom-made mandibular advancement devices for obstructive sleep apnoea: a randomised non-inferiority trial. Thorax. 2019 Jul;74(7):667-674. doi: 10.1136/thoraxjnl-2018-212726. Epub 2019 May 3.