Hypoglossal nerve stimulation for adults with obstructive sleep apnea

Bilateral Hypoglossal Nerve Stimulation With the XII Medical HGNS System for the Treatment of Adult Obstructive Sleep Apnea Pilot Study

This study will test an implanted hypoglossal nerve stimulator to see if it reduces sleep apnea events and improves sleep for adults with moderate to severe OSA who cannot tolerate CPAP.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: XII Medical (industry)
• Locations: 5 sites (Canberra, Australian Capital Territory and 4 other locations)
• Trial ID: NCT07049744 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with moderate-to-severe OSA (AHI 15–50), BMI ≤32 kg/m2, central+mixed apnea index ≤25%, who have not tolerated, failed, or refused PAP are the intended candidates.

Not a fit: Patients with significant positional OSA, complete concentric soft palate collapse on DISE, central sleep apnea, hypoglossal nerve weakness, major airway anatomic abnormalities, high surgical risk, or those taking GLP-1 medications are unlikely to benefit.

Why it matters

Potential benefit: If successful, the device could reduce apneas and improve nighttime breathing and daytime sleepiness for patients who cannot use CPAP.

How similar studies have performed: Other hypoglossal nerve stimulation systems have shown benefit in carefully selected patients with moderate-to-severe OSA, though outcomes vary by device and patient selection.

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

Where this trial is running

Canberra, Australian Capital Territory and 4 other locations

• Canberra ENT — Canberra, Australian Capital Territory, 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

Conditions: Obstructive Sleep Apnea, OSA, HGNS