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NCT05592002 · ClinicalTrials.gov registry record · NA
Safety and Effectiveness of the Genio® bilAteral Stimulation for Treatment of Complete Concentric CollapsE and OSA.
A NA study of Sleep Apnea, Obstructive, sponsored by Nyxoah S.A..
- Active
- Registry status
- NA
- Development phase
- 124
- Enrollment target
- 16
- Study locations
NCT05592002: Active NA study of Sleep Apnea, Obstructive, sponsored by Nyxoah S.A..
NCT05592002 is a NA study of Sleep Apnea, Obstructive that is active but no longer recruiting, run by Nyxoah S.A.. The registered enrollment target is 124 participants, below the 260-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (52% lower). The trial reports 16 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05592002, a NA study of Sleep Apnea, Obstructive, is active but no longer recruiting, sponsored by Nyxoah S.A..
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 124 participants
- Enrollment target
- 16
- Study locations
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.
Primary Outcome
The effectiveness endpoint of the study is assessed through the reduction in the severity of OSA over a period of 12 months post-implant. Primary effectiveness endpoint: percentage of responders based on a change in apnea-hypopnea index (AHI4) and oxygen desaturation index (ODI4) at 12 months post-activation. A responder is defined as any subject with a reduction of 50% in AHI4 from Baseline and a remaining AHI4 \< 20 events/hour (aka "Sher Criteria"), AND 25% in ODI4 from Baseline.
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 |
What the registry record for NCT05592002 still lists
NCT05592002 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 260-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (52% lower).
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.
NCT05592002 lists 16 locations in 12 states (Florida, Pennsylvania, Colorado).
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.
What interventions are being tested in trial NCT05592002?
The interventions under investigation include: Genio System (DEVICE).
Who is sponsoring clinical trial NCT05592002?
This trial is sponsored by Nyxoah S.A., which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Sleep Apnea, Obstructive
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05592002's enrollment target sits among peer trials
124 16th of 45 higher than 30 of 45 other Sleep Apnea, Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep Apnea, Obstructive trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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