Obstructive Sleep Apnea (OSA)BEAT OSANCT07049744
Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea
A study testing XII Medical HGNS System in people with Obstructive Sleep Apnea (OSA), run by XII Medical at 6 sites in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- XII Medical HGNS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesAustralia
- Study dates
- 24 Jun 2025to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Australia6 sites, 6 recruiting
- Recruiting
Princess Alexandra Hospital
Brisbane, Queensland
Elizabeth Herron, +61 (0)7 3176 3219, Elizabeth.Herron@health.qld.gov.au
Leon Kitipornchai, FRACS
- Recruiting
Canberra ENT
Canberra, Australian Capital Territory
Lian Chen, +61 02 6282 4955, Lian.chen@canberrasleeplab.au
Lyndon Chan, FRACS
- Recruiting
Perth Head & Neck Surgery
Perth, Western Australia
Rhea Tecson, +61 8 9386 3033, TecsonR@ramsayhealth.com.au
Richard Lewis, FRACS
- Recruiting
Woolcock Institute Of Medical Research
Sydney, New South Wales, 2113
Thomas Bale Research Assistant, +61 2 9805 3000, thomas.bale@woolcock.org.au
Donald Lee, BSc(Med) MBBS MMed FRACP FCCP
- Recruiting
Westmead Hospital / Chris O'Brien Lifehouse
Sydney, New South Wales
Phoebe Faqihi, PhD, +61 2 8890 7366, Fahimeh.Faqihi@health.nsw.gov.au
Kristina Kairaitis, FRACP PhD
- Recruiting
The Wollongong Hospital
Wollongong, New South Wales, 2500
Jenny Mitchell, +61 2 4222 1346, Jenny.Mitchell1@health.nsw.gov.au
About this study
Official title: Bilateral Hypoglossal Nerve Stimulation With the XII Medical HGNS System for the Treatment of Adult Obstructive Sleep Apnea Pilot Study
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.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- XII Medical HGNS System
- Keywords
- OSA, HGNS
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XII Medical HGNS SystemDevice
XII Medical HGNS System
| Study group | Role | What they receive |
|---|---|---|
| XII Medical HGNS System | Experimental | Participants receiving HGNS using the XII Medical System Receives: Device: XII Medical HGNS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the XII Medical HGNS System
Assessment of serious adverse device events
Measured: Six months post-implantation
Secondary outcomes (2)
Performance of the XII Medical HGNS System
Change from baseline and Responder Rates for the Apnea Hypopnea Index
Measured: Six months post-implantation
Performance of the XII Medical HGNS System
Change from baseline and Responder Rates for the Oxygen Desaturation Index
Measured: Six months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start24 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XII Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049744
- Sponsor's protocol ID
- XII-002
- Acronym
- BEAT OSA
- Status last verified
- Nov 2025
- First submitted
- 25 Jun 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Hypoglossal Nerve Stimulation With the XII Medical HGNS System for the Treatment of Adult Obstructive Sleep Apnea Pilot Study
- ClinicalTrials.gov ID
- NCT07049744
- Acronym / sponsor ID
- BEAT OSA / XII-002
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- OSA, HGNS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- XII MedicalIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XII Medical HGNS System | Experimental | Device: XII Medical HGNS SystemParticipants receiving HGNS using the XII Medical System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- Pregnancy or breast-feeding.
- Significant upper airway anatomic abnormalities
- Hypoglossal nerve weakness
- Central sleep apnoea condition
- Significant positionally-dependent OSA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XII Medical HGNS SystemXII Medical HGNS System | Device | XII Medical HGNS System |
Primary outcome
Safety of the XII Medical HGNS System
Time frame: Six months post-implantation
Assessment of serious adverse device events
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea (OSA)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XII Medical HGNS System in people with Obstructive Sleep Apnea (OSA), run by XII Medical at 6 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor Stuart MacKay FRACS (+61 2 4226 1055, reception@illawarraent.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the XII Medical HGNS System (time frame: Six months post-implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.