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A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults (EliSA)

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ClinicalTrials.gov Identifier: NCT04031040
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Nyxoah S.A.

Brief Summary:
The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio™ system, used according to its instructions for use, in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 3 years post-surgery.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Genio(TM) system therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults.
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Genio(TM) system therapy
Following activation of the Genio™ system at 8 weeks post-surgery, patients will be followed at 12 weeks, 6 months, 10 months, 12 months and then every year for a total period of 3 years after surgery.
Device: Genio(TM) system therapy
Hypoglossal nerve stimulation system




Primary Outcome Measures :
  1. Incidence of all reported Serious Adverse Events (SAEs) and all procedure- or device-related Adverse Events (AEs) [ Time Frame: 12 months post-surgery ]
    Incidence of all reported Serious Adverse Events (SAEs) and all procedure- or device-related Adverse Events (AEs) reported during the study

  2. Change in Apnea-Hypopnea Index from baseline [ Time Frame: 12 months post-surgery ]
    Change in Apnea-Hypopnea Index (AHI) from baseline as measured by sleep lab

  3. Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire [ Time Frame: 12 months post-surgery ]
    Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire (FOSQ)



Information from the National Library of Medicine

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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:

  • Body Mass Index (BMI) < 35 kg/m2
  • AHI between 15 to 65 events/hour documented by a PSG during the screening phase.
  • Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments.

Exclusion Criteria:

  • Night shift worker
  • Significant comorbidities that contraindicates surgery
  • Life expectancy < 12 months
  • Participation in another clinical study (excluding registries) during the study period (3 years).

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): NCT04031040


Contacts
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Contact: Guillaume Raux +32 10 22 48 68 guillaume.raux@nyxoah.com

Locations
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Germany
Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Schlafmedizinisches Zentrum Recruiting
Mannheim, Germany
Contact    +49 151 6740 9957    mbx-hno-schlaf@umm.de   
Sponsors and Collaborators
Nyxoah S.A.
Investigators
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Principal Investigator: Joachim T. Maurer, MD Klinik für HNO-Heilkunde, Mannheim

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Responsible Party: Nyxoah S.A.
ClinicalTrials.gov Identifier: NCT04031040     History of Changes
Other Study ID Numbers: CL-GEN-002068
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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