Sleep ApneaNCT06635265
A Study to Determine the Flow Changes And/or AHI Reduction When Stimulating Two Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea in Adult Subjects
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 1 site in Australia.
Trial summary
This Proof-of-Concept study will collect acute and sub-acute flow and/or AHI data following the placement of lead arrays under direct vision. The acute placement and data collection will be collected following the completion of the pre-scheduled neck dissection surgery. 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
- 3 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Apr 2023to 1 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient 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) < 38 kg/m2.
- Subject must be eligible for neck dissection surgery.
- Written informed consent obtained from the patient 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
- Patients 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.
- Significant tongue weakness.
- Aerodigestive tract tumor or reconstructive surgery performed at the same time as neck dissection.
- Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator.
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- Prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems:
- Airway cancer surgery or radiation, or
- 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.
- Concomitant oral or pharyngeal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Center Proof-of-Concept Study to Determine the Flow Changes And/or AHI Reduction When Stimulating Two Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea in Adult Subjects
This Proof-of-Concept study will collect acute and sub-acute flow and/or AHI data following the placement of lead arrays under direct vision. The acute placement and data collection will be collected following the completion of the pre-scheduled neck dissection surgery. The sub-acute data will be collected in a sleep lab during a polysomnography (PSG). Both data collections will be done when stimulating (using an external pulse generator) the hypoglossal nerve or Genioglossus muscle (GG) and a second neural target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid) with a set of Off-the-Shelf (OTS) electrode arrays.
- 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
Simulation of a combination of: HGN, AC, GG or strap muscles
| Study group | Role | What they receive |
|---|---|---|
| Target stimulation | Experimental | Stimulation of a combination of targets: Hypoglossal nerve (HGN) and Ansa Cervicalis (AC), Genioglossus (GG) and AC, HGN and strap muscles, or GG and strap muscles, during an acute and sub-acute phase. 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.
Impacts on acute airway opening
Demonstration of acute airway opening as visually observed under nasoendoscopy when stimulating the HGN or GG and a second target (neural or direct muscle stimulation).
Measured: Day 0 to 3
Impacts on airflow during a acute assessment
Acute increase in airflow when stimulating the HGN or GG and a second target (neural or direct muscle stimulation), measured by changes in amplitude (mA) during target stimulation.
Measured: Day 0 to 3
Secondary outcomes (1)
Impacts on airway opening during a sub-acute assessment
Demonstration of sub-acute flow increase and/or AHI reduction when stimulating two targets simultaneously during natural sleep as measured with polysomnography (PSG), measured by polysomnography.
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 posted10 Oct 2024
- Study start3 Apr 2023
- Primary completion28 Jun 2024
- Study completion1 Jul 2024
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
- Electrode arrays placed adjacent to nerves are connected to an external pulse generator to evaluate the effect of short-term stimulation on airflow and/or AHI
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invicta Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hollywood Private Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635265
- Sponsor's protocol ID
- IM_004
- Status last verified
- Oct 2024
- First submitted
- 2 Oct 2024
- Last updated
- 10 Oct 2024
- 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 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Proof-of-Concept Study to Determine the Flow Changes And/or AHI Reduction When Stimulating Two Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea in Adult Subjects
- ClinicalTrials.gov ID
- NCT06635265
- Acronym / sponsor ID
- IM_004
- Keywords
- Sleep Apnea device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Invicta Medical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hollywood Private Hospital
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 10 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 will collect acute and sub-acute flow and/or AHI data following the placement of lead arrays under direct vision. The acute placement and data collection will be collected following the completion of the pre-scheduled neck dissection surgery. The sub-acute data will be collected in a sleep lab during a polysomnography (PSG). Both data collections will be done when stimulating (using an external pulse generator) the hypoglossal nerve or Genioglossus muscle (GG) and a second neural target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid) with a set of Off-the-Shelf (OTS) electrode arrays.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Electrode arrays placed adjacent to nerves are connected to an external pulse generator to evaluate the 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 a combination of targets: Hypoglossal nerve (HGN) and Ansa Cervicalis (AC), Genioglossus (GG) and AC, HGN and strap muscles, or GG and strap muscles, during an acute and sub-acute phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A patient 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) < 38 kg/m2.
- Subject must be eligible for neck dissection surgery.
- Written informed consent obtained from the patient prior to performing any study specific procedure.
Key exclusion criteria (13 listed)
- Patients 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.
- Significant tongue weakness.
- Aerodigestive tract tumor or reconstructive surgery performed at the same time as neck dissection.
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)Simulation of a combination of: HGN, AC, GG or strap muscles | Device | Target stimulation |
Primary outcome
Impacts on acute airway opening
Time frame: Day 0 to 3
Demonstration of acute airway opening as visually observed under nasoendoscopy when stimulating the HGN or GG and a second target (neural or direct muscle stimulation).
Impacts on airflow during a acute assessment
Time frame: Day 0 to 3
Acute increase in airflow when stimulating the HGN or GG and a second target (neural or direct muscle stimulation), measured by changes in amplitude (mA) during target stimulation.
1 secondary outcome
Impacts on airway opening during a sub-acute assessment
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 10 Oct 2024.
- 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 Target Stimulation (HGN, AC, GG, Strap muscles) 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 6 inclusion and 13 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 10 Oct 2024. 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?
Impacts on acute airway opening (time frame: Day 0 to 3). The study lists 2 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 10 Oct 2024.