Safety and Effectiveness of the Genio® bilAteral Stimulation for Treatment of Complete Concentric CollapsE and OSA.
Public ClinicalTrials.gov record NCT05592002. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter Study to Assess the Safety and Effectiveness of the Genio® Dual-sided Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnea in Subjects With Complete Concentric Collapse of the Soft Palate.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05592002
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 124 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 28, 2022 (Actual)
- Primary completion
- Sep 2026 (Estimated)
- Completion
- Sep 2028 (Estimated)
- Last update posted
- Sep 5, 2025
2022 – 2028
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Colorado ENT & Allergy | Colorado Springs | Colorado | 80923 | — |
| ENT and Allergy Associates of Florida, LLC | Boca Raton | Florida | 33487 | — |
| University of Miami | Miami | Florida | 33136 | — |
| PharmaDev Clinical Research Institute, | Miami | Florida | 33176 | — |
| University of South Florida | Tampa | Florida | 33620 | — |
| Center for ENT and Allergy, PC Ascension Medical Group | Carmel | Indiana | 46032 | — |
| University of Iowa Institute for Clinical & Translational Science | Iowa City | Iowa | 52242 | — |
| University of Kansas | Kansas City | Kansas | 66160 | — |
| Massachusetts Eye & Ear | Boston | Massachusetts | 02114 | — |
| University of Rochester | Rochester | New York | 14627 | — |
| Hospital of the University Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University Department of Otolaryngology | Philadelphia | Pennsylvania | 19107 | — |
| Bogan Sleep Consultants, LLC | Columbia | South Carolina | 29201 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05592002, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 5, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05592002 live on ClinicalTrials.gov.