Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea
NCT07049744 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-11-18
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
- Obstructive Sleep Apnea (OSA)
Interventions
- DEVICE
-
XII Medical HGNS System
XII Medical HGNS System
Sponsors & Collaborators
-
XII Medical
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-24
- Primary Completion
- 2026-12-31
- Completion
- 2029-06-30
- FDA Device
- Yes
Countries
- Australia
Study Locations
More Related Trials
-
Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy
NCT06720545 ·Status: RECRUITING ·Phase: NA
-
Obstructive Sleep Apnea Therapy by Stimulation of the Hypoglossal Nerve
NCT03844295 ·Status: COMPLETED ·Phase: NA
-
StimAire Sleep Study
NCT05374941 ·Status: TERMINATED ·Phase: NA
-
Effect of Upper Airway Stimulation on Vascular Function in Obstructive Sleep Apnea
NCT03051165 ·Status: TERMINATED ·Phase: NA
-
Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)
NCT01532180 ·Status: COMPLETED ·Phase: NA
-
Hypoglossal Nerve Stimulation on Cardiovascular Outcomes
NCT03359096 ·Status: COMPLETED ·Phase: NA
-
Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
NCT04950894 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement
NCT07132307 ·Status: RECRUITING ·Phase: NA
-
BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse
NCT03763682 ·Status: TERMINATED ·Phase: NA
-
Minimally Invasive Electrical Stimulation Of The Nerve Hypoglossal for the Treatment of Obstructive Sleep Apnea
NCT05914948 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation
NCT07331285 ·Status: NOT_YET_RECRUITING
-
Evaluation of the Restera™ Serene™ System in Adults With Obstructive Sleep Apnea
NCT07303452 ·Status: RECRUITING ·Phase: NA
-
Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation
NCT06317701 ·Status: RECRUITING
-
BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)
NCT03048604 ·Status: COMPLETED ·Phase: NA
-
Proof-of-Concept Study to Determine the Flow Changes When Stimulating Two Neural Targets for the Treatment of Obstructive Sleep Apnea
NCT06415981 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Predicting Outcomes in Hypoglossal Nerve Stimulation Therapy With Stimulated Upper Airway Mechanics
NCT05429983 ·Status: RECRUITING
-
A Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea
NCT06627127 ·Status: RECRUITING ·Phase: NA
-
Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)
NCT02094482 ·Status: COMPLETED ·Phase: NA
-
Stimulation Therapy for Apnea: Reporting Thoughts
NCT04768543 ·Status: COMPLETED
-
Pharmacological Activation of HMN for OSA
NCT03640052 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Effectiveness of the Genio® bilAteral Stimulation for Treatment of Complete Concentric CollapsE and OSA.
NCT05592002 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA
NCT05501236 ·Status: RECRUITING ·Phase: NA
-
Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry
NCT06332404 ·Status: RECRUITING
-
Assessment of the Effect of Hypoglossal Nerve Stimulation Therapy on Upper Airway Collapsibility During Drug-induced Sleep Endoscopy
NCT07337239 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) Obstructive Sleep Apnea Syndrome (OSAS)
NCT03640793 ·Status: COMPLETED ·Phase: NA