Sleep ApneaNCT06627127
A Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (Neural and/or Muscular) for the Treatment of Obstructive Sleep Apnea
A study testing Target stimulation (HGN, AC, GG, Strap muscles) in people with Sleep Apnea and Sleep Apnea, Obstructive, run by Invicta Medical Inc. at 4 sites in Australia.
Trial summary
This proof-of-concept study is to collect acute and short-term sub-acute (if applicable) changes in respiratory parameters following the percutaneous placement of electrode arrays. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
- What is being tested?
- Target stimulation (HGN, AC, GG, Strap muscles)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesAustralia
- Study dates
- 6 Nov 2023to 20 Jan 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject must meet all of the following inclusion criteria to be eligible for inclusion in this study:
- Age above 18 years not under guardianship, under curatorship or under judicial protection.
- Body Mass Index (BMI) < 35 kg/m2.
- OSA (15 < AHI < 80 events/h sleep) documented by a sleep study performed during the past 24 months in the absence of any major weight change or other medical issues.
- Subject must be eligible for a diagnostic DISE or surgical procedure (acute study measures only).
- Written informed consent obtained from the subject prior to performing any study specific procedure.
- Willing and capable to comply with all study requirements, including specific lifestyle considerations, evaluation procedures and questionnaires for the whole duration of the trial.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from participation in this study:
- Major anatomical or functional abnormalities that would impair the ability of the electrode arrays to be positioned.
- Significant comorbidities that contraindicate surgery or general anesthesia/DISE
- Significant tongue weakness
- Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia/DISE in the judgment of the investigator.
- Prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems:
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- Airway cancer surgery or radiation,
- Mandible or maxilla surgery in the previous 3 years (not counting dental treatments),
- Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery),
- Prior hypoglossal nerve stimulation device implantation.
- Currently pregnant, or breastfeeding during the study period
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Adelaide Institute for Sleep Health, Flinders University
Adelaide, South Australia, 5042
Complete ENT
Brisbane, Queensland, 4000
Perth Head and Neck Surgery
Perth, Western Australia, 6009
Illawara ENT
Wollongong, New South Wales, 2500
About this study
Official title: Multicenter Proof-of-Concept Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (Neural and/or Muscular) for the Treatment of Obstructive Sleep Apnea
This proof-of-concept study is to collect acute and short-term sub-acute (if applicable) changes in respiratory parameters following the percutaneous placement of electrode arrays. Acute placement and data collection will be conducted while performing a Drug Induced Sleep Endoscopy (DISE) where the goal will be to quantify changes in airflow with stimulation. Data will also be collected during a one- or two-night polysomnography (PSG) to investigate airflow and sleep stability responses with and without different levels of stimulation during sleep. Where feasible, OSA severity data will be collected, as measured via the apnea/hypopnea index (AHI) with stimulation versus without stimulation as a secondary objective. Both data collections will be done when stimulating the hypoglossal nerve (HGN) or Genioglossus muscle (GG) and a second functional target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid) with a set of electrode arrays either in combination or separately.
- Being tested
- Target stimulation (HGN, AC, GG, Strap muscles)
- Keywords
- Sleep Apnea device
- 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.
Target stimulation (HGN, AC, GG, Strap muscles)Device
Stimulation of the HGN or GG along with AC or strap muscles.
| Study group | Role | What they receive |
|---|---|---|
| Target stimulation | Experimental | Stimulation of the Hypoglossal nerve (HGN) or Genioglossus muscle (GG) and a second functional target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid). Receives: Device: Target stimulation (HGN, AC, GG, Strap muscles) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of technical delivery in stimulating target nerves or muscles
Assessment of the technical ability to simulate the target nerves and/or muscles as observed during nasoendoscopy and ultrasound imaging
Measured: Day 0 to 3
Assessment of the required stimulation amplitude
Assess the required stimulation amplitude measured in milliamps (mA) to improve airflow during stimulation as assessed by direct visualisation of the amplitude.
Measured: Day 0 to 3
Feasibility of participant recruitment and retention
Demonstration of participant recruitment and retention rates for a POC target stimulation in OSA participant study, measured by direct participant recruitment numbers and during on study.
Measured: Day 0 to 30
Secondary outcomes (3)
Acute increase in airflow measured during target stimulation
Demonstration of acute increase in airflow when stimulating the HGN or GG in combination with the AC or strap muscles during a flow limited event (hypopnea or apnea), measured in liters per second (L/s) using pneumotachometer.
Measured: Day 0 to 3
Assessment of acute airway opening during target stimulation
Demonstration of changes in acute cross-sectional airway opening measured under nasoendoscopy when stimulating two functional targets simultaneously (i.e., the HGN and AC). Video imaging and physician interpretation of nasoendoscopic images will be used to review outcome measures.
Measured: Day 0 to 3
Assessment of sub-acute airflow increase and/or AHI reduction during target stimulation during a sleep study.
Demonstration of in sub-acute flow increase and/or AHI reduction when stimulating two functional targets simultaneously during sleep as measured with polysomnography (PSG), measured in liters per second (L/s) using pneumotachometer.
Measured: Day 0 to 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start6 Nov 2023
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Multicenter, proof- of-concept (POC) study. Electrode arrays percutaneously placed under ultrasound adjacent to nerves, connected to an external pulse generator will be used to evaluate the combined effect of short-term stimulation on airflow and/or AHI.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invicta Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adelaide Institute for Sleep Health, The University of Western Australia, Flinders University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627127
- Sponsor's protocol ID
- IM-005
- Status last verified
- Oct 2024
- First submitted
- 24 Jun 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
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
- Multicenter Proof-of-Concept Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (Neural and/or Muscular) for the Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06627127
- Acronym / sponsor ID
- IM-005
- Keywords
- Sleep Apnea device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Invicta Medical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Adelaide Institute for Sleep Health, The University of Western Australia, Flinders University
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 4 Oct 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 to collect acute and short-term sub-acute (if applicable) changes in respiratory parameters following the percutaneous placement of electrode arrays. Acute placement and data collection will be conducted while performing a Drug Induced Sleep Endoscopy (DISE) where the goal will be to quantify changes in airflow with stimulation. Data will also be collected during a one- or two-night polysomnography (PSG) to investigate airflow and sleep stability responses with and without different levels of stimulation during sleep. Where feasible, OSA severity data will be collected, as measured via the apnea/hypopnea index (AHI) with stimulation versus without stimulation as a secondary objective. Both data collections will be done when stimulating the hypoglossal nerve (HGN) or Genioglossus muscle (GG) and a second functional target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid) with a set of electrode arrays either in combination or separately.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter, proof- of-concept (POC) study. Electrode arrays percutaneously placed under ultrasound adjacent to nerves, connected to an external pulse generator will be used to evaluate the combined effect of short-term stimulation on airflow and/or AHI.
| Arm | Type | Receives |
|---|---|---|
| Target stimulation | Experimental | Device: Target stimulation (HGN, AC, GG, Strap muscles)Stimulation of the Hypoglossal nerve (HGN) or Genioglossus muscle (GG) and a second functional target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A subject must meet all of the following inclusion criteria to be eligible for inclusion in this study:
- Age above 18 years not under guardianship, under curatorship or under judicial protection.
- Body Mass Index (BMI) < 35 kg/m2.
- OSA (15 < AHI < 80 events/h sleep) documented by a sleep study performed during the past 24 months in the absence of any major weight change or other medical issues.
- Subject must be eligible for a diagnostic DISE or surgical procedure (acute study measures only).
Key exclusion criteria (11 listed)
- Subjects meeting any of the following criteria will be excluded from participation in this study:
- Major anatomical or functional abnormalities that would impair the ability of the electrode arrays to be positioned.
- Significant comorbidities that contraindicate surgery or general anesthesia/DISE
- Significant tongue weakness
- Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia/DISE in the judgment of the investigator.
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 |
|---|---|---|
| Target stimulation (HGN, AC, GG, Strap muscles)Stimulation of the HGN or GG along with AC or strap muscles. | Device | Target stimulation |
Primary outcome
Feasibility of technical delivery in stimulating target nerves or muscles
Time frame: Day 0 to 3
Assessment of the technical ability to simulate the target nerves and/or muscles as observed during nasoendoscopy and ultrasound imaging
Assessment of the required stimulation amplitude
Time frame: Day 0 to 3
Assess the required stimulation amplitude measured in milliamps (mA) to improve airflow during stimulation as assessed by direct visualisation of the amplitude.
Feasibility of participant recruitment and retention
Time frame: Day 0 to 30
Demonstration of participant recruitment and retention rates for a POC target stimulation in OSA participant study, measured by direct participant recruitment numbers and during on study.
3 secondary outcomes
Acute increase in airflow measured during target stimulation
Time frame: Day 0 to 3
Assessment of acute airway opening during target stimulation
Time frame: Day 0 to 3
Assessment of sub-acute airflow increase and/or AHI reduction during target stimulation during a sleep study.
Time frame: Day 0 to 3
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.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Target stimulation (HGN, AC, GG, Strap muscles) in people with Sleep Apnea and Sleep Apnea, Obstructive, run by Invicta Medical Inc. at 4 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 7 inclusion and 11 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 4 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?
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?
Feasibility of technical delivery in stimulating target nerves or muscles (time frame: Day 0 to 3). The study lists 3 primary outcomes in all. 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 8 Jun 2026.