Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea (NCT07049744) | Clinical Trial Compass
RecruitingNot Applicable
Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea
Australia30 participantsStarted 2025-06-24
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.