Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07049744

Acronym

BEAT OSA

Enrollment

Registered

2025-07-03

Start date

2025-06-24

Completion date

2029-06-01

Last updated

2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

OSA, HGNS

Brief 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.

Interventions

DEVICEXII Medical HGNS System

XII Medical HGNS System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety of the XII Medical HGNS System	Six months post-implantation	Assessment of serious adverse device events

Secondary

Measure	Time frame	Description
Performance of the XII Medical HGNS System	Six months post-implantation	Change from baseline and Responder Rates for the Apnea Hypopnea Index

Countries

Australia

Contacts

CONTACTProfessor Stuart MacKay FRACS

reception@illawarraent.com.au+61 2 4226 1055

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026