Trials / Recruiting
RecruitingNCT07049744
Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea
Bilateral Hypoglossal Nerve Stimulation With the XII Medical HGNS System for the Treatment of Adult Obstructive Sleep Apnea Pilot Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- XII Medical · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this interventional study is to assess the safety and performance of the XII Medical Hypoglossal Nerve Stimulation (HGNS) System in people who have moderate to severe Obstructive Sleep Apnea (OSA). Participation in this study involves being implanted with a Neurostimulator which provides electrical stimulation of the hypoglossal nerve (HGN). Participants will receive treatment at home during sleep, and participate in sleep studies to track and record the quality of the sleep. Participants will be monitored over the course of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | XII Medical HGNS System | XII Medical HGNS System |
Timeline
- Start date
- 2025-06-24
- Primary completion
- 2026-12-01
- Completion
- 2029-06-01
- First posted
- 2025-07-03
- Last updated
- 2025-11-18
Locations
5 sites across 1 country: Australia
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07049744. Inclusion in this directory is not an endorsement.