Hypoglossal nerve stimulation for adults with obstructive sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants will be implanted with the XII Medical hypoglossal nerve stimulation system which delivers targeted electrical pulses to the hypoglossal nerve during sleep. After device implantation, participants will use the device at home overnight and attend scheduled sleep studies to record breathing events and sleep quality. The trial enrolls adults with moderate-to-severe OSA (AHI 15–50) with BMI ≤32 and limited central/mixed apneas, and excludes those with complete concentric palatal collapse, significant positional OSA, or other contraindications to surgery. Safety and device performance will be monitored through follow-up visits and objective sleep testing over the study period.

Why it matters

Who can join: the full rules

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

Where it's running

• Canberra ENT
  Canberra, Australian Capital Territory, Australia Recruiting
• Woolcock Institute Of Medical Research
  Sydney, New South Wales, Australia Recruiting
• Westmead Hospital / Chris O'Brien Lifehouse
  Sydney, New South Wales, Australia Recruiting
• The Wollongong Hospital
  Wollongong, New South Wales, Australia Recruiting
• Princess Alexandra Hospital
  Brisbane, Queensland, Australia Recruiting
• Perth Head & Neck Surgery
  Perth, Western Australia, Australia Recruiting

Study contacts

• Study coordinator: Professor Stuart MacKay FRACS
• Email: reception@illawarraent.com.au
• Phone: +61 2 4226 1055

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.