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Safety and Effectiveness of the Genio® bilAteral Stimulation for Treatment of Complete Concentric CollapsE and OSA.
NCT05592002 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE Genio System
Study Locations (16)
Florida
- ENT and Allergy Associates of Florida, LLC — Boca Raton
- University of Miami — Miami
- PharmaDev Clinical Research Institute, — Miami
- University of South Florida — Tampa
Pennsylvania
- Hospital of the University Pennsylvania — Philadelphia
- Thomas Jefferson University Department of Otolaryngology — Philadelphia
Colorado
- Colorado ENT & Allergy — Colorado Springs
Indiana
- Center for ENT and Allergy, PC Ascension Medical Group — Carmel
Iowa
- University of Iowa Institute for Clinical & Translational Science — Iowa City
Kansas
- University of Kansas — Kansas City
Massachusetts
- Massachusetts Eye & Ear — Boston
New York
- University of Rochester — Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2022-12-28 |
| Est. Completion | 2028-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05592002
The ClinicalTrials.gov registry entry for NCT05592002 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nyxoah S.A., which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Sleep Apnea, Obstructive appearing as the primary indexed condition, and to 1 intervention — of which Genio System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05592002 reports 16 study locations spanning 12 distinct geographic areas — top geographies include Florida, Pennsylvania, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05592002 about?
NCT05592002 is a clinical study titled "Safety and Effectiveness of the Genio® bilAteral Stimulation for Treatment of Complete Concentric CollapsE and OSA.". 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.
What is the current status of trial NCT05592002?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 124 participants. The study started on 2022-12-28. Estimated completion is 2028-09.
What conditions does trial NCT05592002 study?
This clinical trial studies the following conditions: Sleep Apnea, Obstructive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05592002?
The interventions under investigation include: Genio System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05592002?
This trial is sponsored by Nyxoah S.A., which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05592002 being conducted?
This trial has 16 study locations across Colorado, Florida, Indiana, Iowa, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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