NCT07049744 Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea
| NCT ID | NCT07049744 |
| Status | Recruiting |
| Phase | — |
| Sponsor | XII Medical |
| Condition | Obstructive Sleep Apnea (OSA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-06-24 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-06-24 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Body Mass Index (BMI) ≤ 32 kg/m2 * AHI of 15-50 events/hour * Central + mixed apnea index ≤ 25% * Participants who have either not tolerated, have failed or refused positive airway pressure (PAP) Exclusion Criteria: * Pregnancy or breast-feeding. * Significant upper airway anatomic abnormalities * Hypoglossal nerve weakness * Central sleep apnoea condition * Significant positionally-dependent OSA. * Complete concentric patterns of soft palate collapse on DISE * Inadequately treated non-OSA sleep disorder(s). * Significant co-morbidities or prior surgeries that contra-indicate a surgical procedure or general anesthesia * Taking medications that in the opinion of the investigator may alter consciousness, the pattern of respiration, or sleep architecture * Participants on a GLP-1
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07049744 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Obstructive Sleep Apnea (OSA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07049744 currently recruiting?
Yes, NCT07049744 is actively recruiting participants. Contact the research team at reception@illawarraent.com.au for enrollment information.
Where is the NCT07049744 trial being conducted?
This trial is being conducted at Canberra, Australia, Sydney, Australia, Sydney, Australia, Wollongong, Australia and 2 additional locations.
Who is sponsoring the NCT07049744 clinical trial?
NCT07049744 is sponsored by XII Medical. The trial plans to enroll 30 participants.