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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: ONIRIS®; Device: TALI

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • Clinique Bel-Air
  • Boujan sur Libron, France
    • Polyclinique Saint Privat
  • La Tronche, France
    • CHU de Grenoble
  • Le Chesnay, France, 78157
    • Hôpital André Mignot
  • Les Pavillons sous Bois, France, 93320
    • Medical Practice
  • Maisons-Alfort, France
    • Medical Practice
  • Montpellier, France
    • CHU Montpellier
  • Paris, France
    • Fondation Ophtalmologique Adolphe de Rothschild
  • Perpignan, France
    • Medical Practice
  • St Denis, France
    • Centre Cardiologique du Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mandibular advancement devices ONIRIS®; The patients will use the mandibular advancement devices ONIRIS®	Device: ONIRIS®; sleeping test
Active Comparator: laboratory devices TALI; The patients will use the laboratory devices TALI	Device: TALI; sleeping test

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ONIRIS
• Investigators: Principal Investigator: RAYMOND Nathalie, MD, Hôpital Bel Air

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): April 28, 2018
• Study Completion (Actual): April 28, 2018

Study Registration Dates

• First Submitted: January 12, 2015
• First Submitted That Met QC Criteria: January 22, 2015
• First Posted (Estimate): January 28, 2015

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: mandibular advancement devices ONIRIS®; obstructive sleep apnea and hypopneas
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: ONI-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No