Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2019
Source ONIRIS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Mandibular Advancement Devices


Locations

Country Name City State
France Liberal cabinet Paris

Sponsors (1)

Lead Sponsor Collaborator
ONIRIS

Country where clinical trial is conducted

France, 

Outcome

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