Syndrome of Obstructive Sleep Apnea and Hypopneas Clinical Trial
| NCT number | NCT02878629 |
| Other study ID # | OAM Tali® |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2016 |
| Est. completion date | August 2019 |
| Verified date | August 2019 |
| Source | ONIRIS |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The main objective is to evaluate middle term compliance (≥ 2 years) of the Mandibular Advancement Devices Tali® in patients with Syndrome of Obstructive Sleep Apnea and Hypopneas.
| Status | Completed |
| Enrollment | 254 |
| Est. completion date | August 2019 |
| Est. primary completion date | August 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
Inclusion Criteria: - Patients > 18 years treated with Mandibular Advancement Device Tali® from at least 2 years and at the latest 5 years. - Patients who agree to participate to the study. |
| Country | Name | City | State |
|---|---|---|---|
| France | Liberal cabinet | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| ONIRIS |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | compliance (no stop of the Mandibular Advancement Device) | 2 years or more after the beginning of device |