Sleep ApneaNCT06283017
Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea
A study testing Hypoglossal nerve stimulation in people with Sleep Apnea and Sleep Apnea, Obstructive, run by Invicta Medical Inc. at 1 site in Australia.
Trial summary
This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Disorder
- What is being tested?
- Hypoglossal nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Apr 2022to 27 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be eligible for a diagnostic or surgical procedure and
- Suffers from OSA (apnea/hypopnea index >10 event/h sleep) based on history and a physical exam.
- Is a surgical candidate.
- Is willing and capable of providing informed consent.
- Is willing to have a representative electrode array temporarily placed in the submandibular and mylohyoid space.
- Is willing to participate in the designated follow-up visits.
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- Must be in good general health.
- Is able to understand and has voluntarily signed and dated the IRB or EC approved informed consent form (ICF) prior to initiation of any screening or study-specific procedure.
- Must be minimum of 18 years and maximum 80 years of age.
Who cannot join
- Has Body Mass Index above 35 kg/m2.
- Has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
- Has significant co-morbidities making them unable or inappropriate to participate in this POC study.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Adelaide Institute for Sleep Health, Flinders University
Adelaide, South Australia, 5042
About this study
Official title: Acute Proof-of-Concept Study to Evaluate Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea
This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed.
- Being tested
- Hypoglossal nerve stimulation
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoglossal nerve stimulationDevice
Device stimulation of the hypoglossal nerve
| Study group | Role | What they receive |
|---|---|---|
| Hypoglossal nerve stimulation | Experimental | Device-mediated stimulation of the hypoglossal nerve Receives: Device: Hypoglossal nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target identification and access outcomes
Identification of and access to the target stimulation location aligned with the medial branch of the Hypoglossal Nerve
Measured: Day 0
Tongue protrusion outcomes
Visual verification of protrusion of the tongue during stimulation at the target stimulation location with a representative electrode array.
Measured: Day 0
Characterization of lead placement outcomes
Spatial characterization of the orientation of the electrode array and lead body to the target stimulation location considering suitable chronic anchoring locations.
Measured: Day 0
Lead placement and removal outcomes
To demonstrate the ability to safely place and remove the electrode array, per protocol instructions.
Measured: Day 0
Safety outcomes
To evaluate and report all observed adverse events, serious adverse events, unanticipated adverse events and adverse device effects observed during the study
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start6 Apr 2022
- Primary completion27 Feb 2024
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invicta Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adelaide Institute for Sleep Health, Flinders University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283017
- Sponsor's protocol ID
- IM-002
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Osman AM, Carney AS, Ooi EH, Joshi H, Toson B, Tran C, Hudson AL, Nguyen P, Gelekis N, Eastwood PR, Catcheside P, Eckert DJ. Effect of Novel Hypoglossal Stimulation on Airflow and Airway Collapsibility in OSA. Chest. 2026 Jan;169(1):257-268. doi: 10.1016/j.chest.2025.08.020. Epub 2025 Sep 6.
PubMed 40921399
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Proof-of-Concept Study to Evaluate Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06283017
- Acronym / sponsor ID
- IM-002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Invicta Medical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Adelaide Institute for Sleep Health, Flinders University
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 28 Feb 2024 (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.
This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypoglossal nerve stimulation | Experimental | Device: Hypoglossal nerve stimulationDevice-mediated stimulation of the hypoglossal nerve |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject must be eligible for a diagnostic or surgical procedure and
- Suffers from OSA (apnea/hypopnea index >10 event/h sleep) based on history and a physical exam.
- Is a surgical candidate.
- Is willing and capable of providing informed consent.
- Is willing to have a representative electrode array temporarily placed in the submandibular and mylohyoid space.
Key exclusion criteria (3 listed)
- Has Body Mass Index above 35 kg/m2.
- Has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
- Has significant co-morbidities making them unable or inappropriate to participate in this POC study.
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 |
|---|---|---|
| Hypoglossal nerve stimulationDevice stimulation of the hypoglossal nerve | Device | Hypoglossal nerve stimulation |
Primary outcome
Target identification and access outcomes
Time frame: Day 0
Identification of and access to the target stimulation location aligned with the medial branch of the Hypoglossal Nerve
Tongue protrusion outcomes
Time frame: Day 0
Visual verification of protrusion of the tongue during stimulation at the target stimulation location with a representative electrode array.
Characterization of lead placement outcomes
Time frame: Day 0
Spatial characterization of the orientation of the electrode array and lead body to the target stimulation location considering suitable chronic anchoring locations.
Lead placement and removal outcomes
Time frame: Day 0
To demonstrate the ability to safely place and remove the electrode array, per protocol instructions.
Safety outcomes
Time frame: Day 30
To evaluate and report all observed adverse events, serious adverse events, unanticipated adverse events and adverse device effects observed during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Results publication: PubMed 40921399Osman AM, Carney AS, Ooi EH, Joshi H, Toson B, Tran C, Hudson AL, Nguyen P, Gelekis N, Eastwood PR, Catcheside P, Eckert DJ. Effect of Novel Hypoglossal Stimulation on Airflow and Airway Collapsibility in OSA. Chest. 2026 Jan;169(1):257-268. doi: 10.1016/j.chest.2025.08.020. Epub 2025 Sep 6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoglossal nerve stimulation in people with Sleep Apnea and Sleep Apnea, Obstructive, run by Invicta Medical Inc. at 1 site 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 9 inclusion and 3 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: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target identification and access outcomes (time frame: Day 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06283017, which also lists 1 linked publication.
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 8 Jun 2026.