Sleep ApneaNCT06415981
Proof-of-Concept Study to Determine the Flow Changes When Stimulating Two Neural Targets for the Treatment of Obstructive Sleep Apnea
A study testing Hypoglossal nerve and/or Ansa Cervicalis stimulation in people with Sleep Apnea and Sleep Apnea, Obstructive, run by Invicta Medical Inc. at 1 site in United Kingdom.
Trial summary
This proof-of-concept study will evaluate the impact of surgically placing and stimulating the hypoglossal nerve and/or a second neural target Ansa Cervicalis, with a set of off-the-shelf 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 Disorder
- What is being tested?
- Hypoglossal nerve and/or Ansa Cervicalis stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Dec 2022to 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
- Age above 18 years not under guardianship, under curatorship or under judicial protection.
- Body Mass Index (BMI) < 35 kg/m2.
- Subject suffers from OSA (15 < AHI < 80) documented by a sleep study performed during the past 36 months.
- Subject must be eligible for a diagnostic or surgical procedure.
- 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
- 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
- Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator.
- Prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems:
- Airway cancer surgery or radiation,
Show all 10Show fewer
- 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
1 site in 1 country.
United Kingdom1 site
University College London Hospital
London, NWI 2PG
About this study
Official title: Single Center Proof-of-Concept Study to Determine the Flow Changes When Stimulating Two Neural Targets for the Treatment of Obstructive Sleep Apnea
This proof-of-concept study will evaluate the impact of surgically placing and stimulating the hypoglossal nerve and/or a second neural target Ansa Cervicalis, with a set of off-the-shelf electrode arrays.
- Being tested
- Hypoglossal nerve and/or Ansa Cervicalis stimulation
- Keywords
- Sleep Apnea
- 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 and/or Ansa Cervicalis stimulationDevice
Device stimulation of the hypoglossal nerve and/or Ansa Cervicalis
| Study group | Role | What they receive |
|---|---|---|
| Hypoglossal nerve and/or Ansa Cervicalis stimulation | Experimental | Not described Receives: Device: Hypoglossal nerve and/or Ansa Cervicalis stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of participants with changes in cross-sectional area airway opening during target stimulation
Assessment of patients with changes in acute cross-sectional area airway opening measured in cm2 under nasoendoscopy when stimulating two neural targets (the HGN and AC). Video imaging and physician interpretation of nasoendoscopic images will be used to review outcome measures.
Measured: Day 0
Assessment of changes in airflow outcomes
Assessment of acute changes in airflow when stimulating the HGN in combination with the AC during a flow limited event (hypopnea or apnea).
Measured: Day 0
Secondary outcomes (1)
Number of participant adverse events observed during the study
To evaluate and report all observed participant adverse events observed during 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 posted16 May 2024
- Study start21 Dec 2022
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invicta Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415981
- Sponsor's protocol ID
- IM-003
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 16 May 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 16 May 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 When Stimulating Two Neural Targets for the Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06415981
- Acronym / sponsor ID
- IM-003
- Keywords
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Invicta Medical Inc.Industry (pharma, biotech, devices)
- Collaborators
- University College London Hospitals
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 16 May 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 evaluate the impact of surgically placing and stimulating the hypoglossal nerve and/or a second neural target Ansa Cervicalis, with a set of off-the-shelf electrode arrays.
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 and/or Ansa Cervicalis stimulation | Experimental | Device: Hypoglossal nerve and/or Ansa Cervicalis stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age above 18 years not under guardianship, under curatorship or under judicial protection.
- Body Mass Index (BMI) < 35 kg/m2.
- Subject suffers from OSA (15 < AHI < 80) documented by a sleep study performed during the past 36 months.
- Subject must be eligible for a diagnostic or surgical procedure.
- Written informed consent obtained from the patient prior to performing any study specific procedure.
Key exclusion criteria (10 listed)
- 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
- Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator.
- Prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems:
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 and/or Ansa Cervicalis stimulationDevice stimulation of the hypoglossal nerve and/or Ansa Cervicalis | Device | Hypoglossal nerve and/or Ansa Cervicalis stimulation |
Primary outcome
Incidence of participants with changes in cross-sectional area airway opening during target stimulation
Time frame: Day 0
Assessment of patients with changes in acute cross-sectional area airway opening measured in cm2 under nasoendoscopy when stimulating two neural targets (the HGN and AC). Video imaging and physician interpretation of nasoendoscopic images will be used to review outcome measures.
Assessment of changes in airflow outcomes
Time frame: Day 0
Assessment of acute changes in airflow when stimulating the HGN in combination with the AC during a flow limited event (hypopnea or apnea).
1 secondary outcome
Number of participant adverse events observed during the study
Time frame: Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
Related trials for Sleep Apnea
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Recruiting
A Study of the Sleepnet Elara APAP Device
Sleep Apnea - Obstructive
Not yet recruiting
Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
Obstructive Sleep Apnea
Not yet recruiting
Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea With Complete Concentric Collapse
Obstructive Sleep Apnea
Active, not recruitingObservational study
Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis
Bronchiectasis, Sleep-Disordered Breathing
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 and/or Ansa Cervicalis stimulation in people with Sleep Apnea and Sleep Apnea, Obstructive, run by Invicta Medical Inc. at 1 site in United Kingdom.
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 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: status not confirmed, as of the sponsor's last update on 16 May 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 United Kingdom. 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?
Results are not available in the source record.
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?
Incidence of participants with changes in cross-sectional area airway opening during target stimulation (time frame: Day 0). 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 16 May 2024.