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

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ClinicalTrials.gov Identifier: NCT02348970
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
ONIRIS

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: ONIRIS® Device: TALI Not Applicable

Detailed Description:
Open, non-inferiority, controlled and rndomised clinical trial. Six months of inclusion. Each included patient will be followed during 12 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2015
Actual Primary Completion Date : April 28, 2018
Actual Study Completion Date : April 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: mandibular advancement devices ONIRIS®
The patients will use the mandibular advancement devices ONIRIS®
Device: ONIRIS®
sleeping test

Active Comparator: laboratory devices TALI
The patients will use the laboratory devices TALI
Device: TALI
sleeping test




Primary Outcome Measures :
  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. [ Time Frame: 2 monthes 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 :
  1. Evolution of AHI, AI and HI [ Time Frame: at M2 and at M12 ]
    AHI per hour of sleep with the same modalities as the one used for diagnosis (realised by ambulatory PG or PSG)

  2. Percentage of patients responder [ Time Frame: at M2 and M12 ]
    Percentage of patients responder at the last control exam

  3. Evolution during the study of the principal criteria concerning the sleep [ Time Frame: at baseline, M2, M6 and M12 ]
    Snoring measured by VAS, Epworth Sleepness Scale measuring daytime sleepness, Pichot Questionnaire measuring fatigue and depression

  4. Evolution of the quality of life [ Time Frame: at baseline, M2, M6 and M12 ]
    Quality of life evaluated by SF12 at each visit

  5. Evolution of the compliance [ Time Frame: at M2, M6 and M12 ]
    Percantage of compliance (excellent > 85%, good > 50%)

  6. Evolution of tolerance [ Time Frame: at M2, M6 and M12 ]
    Nature, frequency and intensity of AE at each visit

  7. AE and SAE occuring during the study [ Time Frame: at M2, M6 and M12 ]
    Description and comparison at each group of AE and SAE

  8. Evolution of arterial hypertension [ Time Frame: at baseline, M2, M6 and M12 ]
    Arterial hypertension evaluated at each visit



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348970


Locations
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France
Clinique Bel-Air
Bordeaux, France
Polyclinique Saint Privat
Boujan sur Libron, France
CHU de Grenoble
La Tronche, France
Hôpital André Mignot
Le Chesnay, France, 78157
Medical Practice
Les Pavillons sous Bois, France, 93320
Medical Practice
Maisons-Alfort, France
CHU Montpellier
Montpellier, France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, France
Medical Practice
Perpignan, France
Centre Cardiologique du Nord
St Denis, France
Sponsors and Collaborators
ONIRIS
Investigators
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Principal Investigator: RAYMOND Nathalie, MD Hôpital Bel Air

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ONIRIS
ClinicalTrials.gov Identifier: NCT02348970     History of Changes
Other Study ID Numbers: ONI-003
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by ONIRIS:
mandibular advancement devices ONIRIS®
obstructive sleep apnea and hypopneas
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases