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

Obstructive Sleep Apnea Clinical Trial

— IRIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348970
• Other study ID #: ONI-003
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: April 28, 2018

Study information

• Verified date: August 2018
• Source: ONIRIS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: April 28, 2018
• Est. primary completion date: April 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• ONIRIS®
sleeping test
• TALI
sleeping test

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ONIRIS

Country where clinical trial is conducted

France, 

Outcome

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