Active — Not RecruitingNot Applicable

Safety and Effectiveness of the Genio® bilAteral Stimulation for Treatment of Complete Concentric CollapsE and OSA.

United States124 participantsStarted 2022-12-28

Plain-language summary

The solution offered by the Genio System to treat OSA patients with CCC using bilateral HGNS has a favorable risk-benefit ratio, as demonstrated by evidence from 2 studies.

Who can participate

Age range22 Years – 75 Years

SexALL

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Exclusion criteria

✕. Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment:
✕. Severe chronic insomnia,
✕. Insufficient sleep syndrome (\<6 hours sleep per night),
✕. Narcolepsy,
✕. Restless legs syndrome,
✕. REM behavior disorder,
✕. Others deemed sufficient disorders that would confound functional sleep assessment in the judgment of the investigator.
✕. Taking medications that may alter consciousness, the pattern of respiration, or sleep architecture as determined by the investigator.

What they're measuring

Primary Effectiveness Endpoint

Timeframe: The duration of the study is expected to be approximately 4.5 years.

Trial details

NCT IDNCT05592002

SponsorNyxoah S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09

View on ClinicalTrials.gov More Sleep Apnea, Obstructive trials