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OpenTrials
Completed

NCT Number: NCT02348970

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

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.

Completed

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Bel-Air, Bordeaux, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONIRIS®

Device

sleeping test

TALI

Device

sleeping test

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.

    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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ONIRIS

Industry

Registry information

Official study 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

Acronym: IRIS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 28, 2015
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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