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NCT Number: NCT07049744

Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea

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.

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canberra ENT, Canberra, Australian Capital Territory, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XII Medical HGNS System

Device

XII Medical HGNS System

Primary outcomes

  1. Safety of the XII Medical HGNS System

    Time frame: Six months post-implantation

    Assessment of serious adverse device events

Secondary outcomes

  1. Performance of the XII Medical HGNS System

    Time frame: Six months post-implantation

    Change from baseline and Responder Rates for the Apnea Hypopnea Index

  2. Performance of the XII Medical HGNS System

    Time frame: Six months post-implantation

    Change from baseline and Responder Rates for the Oxygen Desaturation Index

Study contacts

Contact information is provided by the study sponsor or research team.

Professor Stuart MacKay FRACS

CONTACT

[email protected]

+61 2 4226 1055

Sponsors and collaborators

Lead sponsor

XII Medical

Industry

Registry information

Official study title

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

Acronym: BEAT OSA

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Jul 3, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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