Sleep ApneaNCT06283030
Evaluation 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 United States.
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 21 to 80 years
- Conditions the study is for
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
- 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 siteUnited States
- Study dates
- 14 Jan 2022to 31 May 2023
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be eligible for an OSA diagnostic or surgical procedure.
- Subject suffers with moderate to severe OSA based on history and a physical exam.
- Subject has failed, refused or has not tolerated CPAP treatment.
- Subject is willing and capable of providing informed consent.
- Subject is willing to have a representative electrode array temporarily placed in the submandibular, sublingual and mylohyoid space.
- --Subject is willing to participate in the designated follow-up visits.
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- Subject must be in good general health.
- Subject 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.
- Subject must be minimum of 21 years and maximum 80 years of age.
- Subject's Hypoglossal Nerve must be able to be visualized using ultrasound
Who cannot join
- Subject has Body Mass Index above 38kg/m2.
- Subject has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
- Subject has significant co-morbidities making them unable or inappropriate to participate in this POC study.
- Subject plans to become pregnant, is currently pregnant or breastfeeding during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Bill Wilkerson Centre
Nashville, Tennessee, 37232
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-mediated stimulation of the hypoglossal nerve
| Study group | Role | What they receive |
|---|---|---|
| Hypoglossal nerve stimulation | Experimental | Not described Receives: Device: Hypoglossal nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and access of the target outcomes
Consistent 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 electrode array 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
Electrode array 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 start14 Jan 2022
- Primary completion31 May 2023
- Study completion31 May 2023
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
- Vanderbilt University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283030
- Sponsor's protocol ID
- IM-001
- 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
Kent DT, Li Y. Percutaneous Approaches to Hypoglossal Nerve Stimulation: A Pilot Study During Drug-Induced Sleep Endoscopy. Otolaryngol Head Neck Surg. 2024 Oct;171(4):1250-1253. doi: 10.1002/ohn.880. Epub 2024 Jun 29.
PubMed 38943442
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
- NCT06283030
- Acronym / sponsor ID
- IM-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Invicta Medical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University Medical Center
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (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 stimulation |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject must be eligible for an OSA diagnostic or surgical procedure.
- Subject suffers with moderate to severe OSA based on history and a physical exam.
- Subject has failed, refused or has not tolerated CPAP treatment.
- Subject is willing and capable of providing informed consent.
- Subject is willing to have a representative electrode array temporarily placed in the submandibular, sublingual and mylohyoid space.
Key exclusion criteria (4 listed)
- Subject has Body Mass Index above 38kg/m2.
- Subject has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
- Subject has significant co-morbidities making them unable or inappropriate to participate in this POC study.
- Subject plans to become pregnant, is currently pregnant or breastfeeding during the study period.
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-mediated stimulation of the hypoglossal nerve | Device | Hypoglossal nerve stimulation |
Primary outcome
Identification and access of the target outcomes
Time frame: Day 0
Consistent 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 electrode array 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.
Electrode array 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 38943442Kent DT, Li Y. Percutaneous Approaches to Hypoglossal Nerve Stimulation: A Pilot Study During Drug-Induced Sleep Endoscopy. Otolaryngol Head Neck Surg. 2024 Oct;171(4):1250-1253. doi: 10.1002/ohn.880. Epub 2024 Jun 29.
- 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 United States.
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 10 inclusion and 4 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 United States. 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?
Identification and access of the target 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 NCT06283030, 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.