Obstructive Sleep Apnea
Conditions
Keywords
mandibular advancement devices ONIRIS®, obstructive sleep apnea and hypopneas
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.
Interventions
DEVICEONIRIS®
sleeping test
DEVICETALI
sleeping test
Sponsors
ONIRIS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 of the quality of life | at baseline, M2, M6 and M12 | Quality of life evaluated by SF12 at each visit |
| Evolution of the compliance | at M2, M6 and M12 | Percantage of compliance (excellent \> 85%, good \> 50%) |
| Evolution of tolerance | at M2, M6 and M12 | Nature, frequency and intensity of AE 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 arterial hypertension | at baseline, M2, M6 and M12 | Arterial hypertension evaluated at each visit |
Countries
France
Outcome results
None listed