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Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea

Key facts

Who runs it
XII Medical
Where
Australia6 sites in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
30 people, planned
Started
24 Jun 2025
Expected to end
Jun 2029
Type of study
Interventional
Treatments tested
  • XII Medical HGNS System
Record updated
30 July 2026

Who can take part

Age
21 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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)

Who cannot take part

  • 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
  • Central sleep apnoea condition
  • Inadequately treated non-OSA sleep disorder(s)
  • Pregnancy or breast-feeding
  • Significant upper airway anatomic abnormalities
  • Hypoglossal nerve weakness
  • Significant positionally-dependent OSA
  • Complete concentric patterns of soft palate collapse on DISE
  • Participants on a GLP-1

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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.

The group in the trial

  • XII Medical HGNS SystemTreatment being tested

    Participants receiving HGNS using the XII Medical System

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Bilateral Hypoglossal Nerve Stimulation With the XII Medical HGNS System for the Treatment of Adult Obstructive Sleep Apnea Pilot Study
Record updated
30 July 2026