NCT02878629

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

3.1 years

First QC Date

August 22, 2016

Last Update Submit

August 27, 2019

Conditions

Syndrome of Obstructive Sleep Apnea and Hypopneas

Outcome Measures

Primary Outcomes (1)

  • compliance (no stop of the Mandibular Advancement Device)

    2 years or more after the beginning of device

Interventions

Mandibular Advancement DevicesDEVICE

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients \> 18 years treated with Mandibular Advancement Device Tali® from at least 2 years and at the latest 5 years.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liberal cabinet

Paris, 75008, France

Location

MeSH Terms

Interventions

Occlusal Splints

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 25, 2016

Study Start

July 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

FR(1)