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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- ONIRIS
- Enrollment
- 211
- Locations
- 8
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
Time Frame: 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 Outcomes
- Evolution of tolerance(at M2, M6 and M12)
- Evolution of the quality of life(at baseline, M2, M6 and M12)
- AE and SAE occuring during the study(at M2, M6 and M12)
- Evolution of AHI, AI and HI(at M2 and at M12)
- Percentage of patients responder(at M2 and M12)
- Evolution during the study of the principal criteria concerning the sleep(at baseline, M2, M6 and M12)
- Evolution of the compliance(at M2, M6 and M12)
- Evolution of arterial hypertension(at baseline, M2, M6 and M12)