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Efficacy and Compliance of the Mandibular Advancement Devices ONIRIS® vs. Custom Made Devices (IRIS)

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ONIRIS®
TALI
Sponsored by
ONIRIS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring mandibular advancement devices ONIRIS®, obstructive sleep apnea and hypopneas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique Bel-Air
  • Polyclinique Saint Privat
  • CHU de Grenoble
  • Hôpital André Mignot
  • Medical Practice
  • Medical Practice
  • CHU Montpellier
  • Fondation Ophtalmologique Adolphe de Rothschild
  • Medical Practice
  • Centre Cardiologique du Nord

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mandibular advancement devices ONIRIS®

laboratory devices TALI

Arm Description

The patients will use the mandibular advancement devices ONIRIS®

The patients will use the laboratory devices TALI

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evolution of AHI, AI and HI
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
Percentage of patients responder at the last control exam
Evolution during the study of the principal criteria concerning the sleep
Snoring measured by VAS, Epworth Sleepness Scale measuring daytime sleepness, Pichot Questionnaire measuring fatigue and depression
Evolution of the quality of life
Quality of life evaluated by SF12 at each visit
Evolution of the compliance
Percantage of compliance (excellent > 85%, good > 50%)
Evolution of tolerance
Nature, frequency and intensity of AE at each visit
AE and SAE occuring during the study
Description and comparison at each group of AE and SAE
Evolution of arterial hypertension
Arterial hypertension evaluated at each visit

Full Information

First Posted
January 12, 2015
Last Updated
August 29, 2018
Sponsor
ONIRIS
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1. Study Identification

Unique Protocol Identification Number
NCT02348970
Brief Title
Efficacy and Compliance of the Mandibular Advancement Devices ONIRIS® vs. Custom Made Devices
Acronym
IRIS
Official Title
Multicenters, Randomised Clinical Trial, to Evaluate Efficacy and Compliance of Mandibular Advancement Devices ONIRIS® vs. Laboratory Devices TALI in Patients With Syndrome of Obstructive Sleep Apnea and Hypopneas
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
April 28, 2018 (Actual)
Study Completion Date
April 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ONIRIS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
mandibular advancement devices ONIRIS®, obstructive sleep apnea and hypopneas

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mandibular advancement devices ONIRIS®
Arm Type
Experimental
Arm Description
The patients will use the mandibular advancement devices ONIRIS®
Arm Title
laboratory devices TALI
Arm Type
Active Comparator
Arm Description
The patients will use the laboratory devices TALI
Intervention Type
Device
Intervention Name(s)
ONIRIS®
Intervention Description
sleeping test
Intervention Type
Device
Intervention Name(s)
TALI
Intervention Description
sleeping test
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
2 monthes of use
Secondary Outcome Measure Information:
Title
Evolution of AHI, AI and HI
Description
AHI per hour of sleep with the same modalities as the one used for diagnosis (realised by ambulatory PG or PSG)
Time Frame
at M2 and at M12
Title
Percentage of patients responder
Description
Percentage of patients responder at the last control exam
Time Frame
at M2 and M12
Title
Evolution during the study of the principal criteria concerning the sleep
Description
Snoring measured by VAS, Epworth Sleepness Scale measuring daytime sleepness, Pichot Questionnaire measuring fatigue and depression
Time Frame
at baseline, M2, M6 and M12
Title
Evolution of the quality of life
Description
Quality of life evaluated by SF12 at each visit
Time Frame
at baseline, M2, M6 and M12
Title
Evolution of the compliance
Description
Percantage of compliance (excellent > 85%, good > 50%)
Time Frame
at M2, M6 and M12
Title
Evolution of tolerance
Description
Nature, frequency and intensity of AE at each visit
Time Frame
at M2, M6 and M12
Title
AE and SAE occuring during the study
Description
Description and comparison at each group of AE and SAE
Time Frame
at M2, M6 and M12
Title
Evolution of arterial hypertension
Description
Arterial hypertension evaluated at each visit
Time Frame
at baseline, M2, M6 and M12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RAYMOND Nathalie, MD
Organizational Affiliation
Hôpital Bel Air
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Bel-Air
City
Bordeaux
Country
France
Facility Name
Polyclinique Saint Privat
City
Boujan sur Libron
Country
France
Facility Name
CHU de Grenoble
City
La Tronche
Country
France
Facility Name
Hôpital André Mignot
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
Medical Practice
City
Les Pavillons sous Bois
ZIP/Postal Code
93320
Country
France
Facility Name
Medical Practice
City
Maisons-Alfort
Country
France
Facility Name
CHU Montpellier
City
Montpellier
Country
France
Facility Name
Fondation Ophtalmologique Adolphe de Rothschild
City
Paris
Country
France
Facility Name
Medical Practice
City
Perpignan
Country
France
Facility Name
Centre Cardiologique du Nord
City
St Denis
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31053619
Citation
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.
Results Reference
derived

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Efficacy and Compliance of the Mandibular Advancement Devices ONIRIS® vs. Custom Made Devices

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