TerminatedNot Applicable

BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse

Stopped: The study was terminated due to operational challenges impacting protocol execution across sites.

Australia42 participantsStarted 2019-01-10

Plain-language summary

The objective of this study is to explore the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate over a period of 4.5 months of treatment (i.e. 6 months post-surgery) measured by the AHI, at rest to determine if there is a difference in performance between the two populations.

Who can participate

Age range21 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Man or woman between 21 and 75 years of age * Body mass index (BMI) ≤ 32 kg/m2 * Obstructive apnoea-hypopnea index (AHI) of 15-50 events/hour * Participants who have either not tolerated, have failed or refused positive airway pressure (PAP) treatments. Exclusion Criteria: * Unable or incapable of providing informed written consent * Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires

What they're measuring

Incidence of serious device-related adverse events recorded during the study

Timeframe: 6 months

Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)

Timeframe: Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)

Trial details

NCT IDNCT03763682

SponsorNyxoah S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-28

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials