NCT02348970

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
211

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

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

January 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

3.3 years

First QC Date

January 12, 2015

Last Update Submit

August 29, 2018

Conditions

Obstructive Sleep Apnea

Keywords

mandibular advancement devices ONIRIS®obstructive sleep apnea and hypopneas

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    2 monthes of use

Secondary Outcomes (8)

  • 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 quality of life

    at baseline, M2, M6 and M12

  • Evolution of the compliance

    at M2, M6 and M12

  • +3 more secondary outcomes

Study Arms (2)

mandibular advancement devices ONIRIS®

EXPERIMENTAL

The patients will use the mandibular advancement devices ONIRIS®

Device: ONIRIS®

laboratory devices TALI

ACTIVE COMPARATOR

The patients will use the laboratory devices TALI

Device: TALI

Interventions

ONIRIS®DEVICE

sleeping test

mandibular advancement devices ONIRIS®
TALIDEVICE

sleeping test

laboratory devices TALI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Clinique Bel-Air

Bordeaux, France

Location

Polyclinique Saint Privat

Boujan-sur-Libron, France

Location

CHU de Grenoble

La Tronche, France

Location

Hôpital André Mignot

Le Chesnay, 78157, France

Location

Medical Practice

Les Pavillons-sous-Bois, 93320, France

Location

Medical Practice

Maisons-Alfort, France

Location

CHU Montpellier

Montpellier, France

Location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, France

Location

Medical Practice

Perpignan, France

Location

Centre Cardiologique du Nord

Saint-Denis, France

Location

Related Publications (1)

  • Pepin JL, Raymond N, Lacaze O, Aisenberg N, Forcioli J, Bonte E, Bourdin A, Launois S, Tamisier R, Molinari N. Heat-moulded versus custom-made mandibular advancement devices for obstructive sleep apnoea: a randomised non-inferiority trial. Thorax. 2019 Jul;74(7):667-674. doi: 10.1136/thoraxjnl-2018-212726. Epub 2019 May 3.

    PMID: 31053619DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • RAYMOND Nathalie, MD

    Hôpital Bel Air

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 28, 2015

Study Start

January 1, 2015

Primary Completion

April 28, 2018

Study Completion

April 28, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(10)