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Recruiting NCT07049744

Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea

No phase Interventional Obstructive Sleep Apnea (OSA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: XII Medical HGNS System.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea (OSA). Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Device XII Medical HGNS System
    XII Medical HGNS System

Primary outcome measures

  • Safety of the XII Medical HGNS System [Time frame: Six months post-implantation]
Secondary outcome measures (2)
  • Performance of the XII Medical HGNS System [Time frame: Six months post-implantation]
  • Performance of the XII Medical HGNS System [Time frame: Six months post-implantation]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

Australia · 6 centers
  • Canberra ENT — Canberra
  • Woolcock Institute Of Medical Research — Sydney
  • Westmead Hospital / Chris O'Brien Lifehouse — Sydney
  • The Wollongong Hospital — Wollongong
  • Princess Alexandra Hospital — Brisbane
  • Perth Head & Neck Surgery — Perth

Identifiers

NCT: NCT07049744 · XII-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗