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

  • End date
    Oct 30, 2025
  • participants needed
  • sponsor
    Nyxoah S.A.
Updated on 21 March 2022
body mass index


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.


This study is a multicenter, prospective single arm PMCF. Following activation of the Genio™ system between 6 to 10 weeks post-surgery, patients will be followed at 3 months, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery. Phone calls follow-up will be performed at Month 18, Month 30, Month 42 and Month 54.

Condition Obstructive Sleep Apnea
Treatment Genio(TM) system therapy
Clinical Study IdentifierNCT04031040
SponsorNyxoah S.A.
Last Modified on21 March 2022


Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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