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Active, not recruitingNCT06415981Updated May 16, 2024

Proof-of-Concept Study to Determine the Flow Changes When Stimulating Two Neural Targets for the Treatment of Obstructive Sleep Apnea

An interventional study of Hypoglossal nerve and/or Ansa Cervicalis stimulation in Sleep Apnea, Sleep Apnea, Obstructive and Sleep Disorder, sponsored by Invicta Medical Inc.. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Invicta Medical Inc. · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as active, not recruiting.
  • Registered 1 year 4 months after the study started (first participant enrolled Dec 2022, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Sleep Apnea
  • Sleep Apnea, Obstructive
  • Sleep Disorder
  • Sleep Apnea Syndromes

Keywords

  • Sleep Apnea
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In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 7 is below the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Invicta Medical Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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,
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Hypoglossal nerve and/or Ansa Cervicalis stimulation

    Device: Hypoglossal nerve and/or Ansa Cervicalis stimulation

Interventions

  • DeviceHypoglossal nerve and/or Ansa Cervicalis stimulation

    Device stimulation of the hypoglossal nerve and/or Ansa Cervicalis

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 0

  2. 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).

    Time frame: 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.

    Time frame: Day 30

07

Study locations

1 site
  • University College London Hospital
    London, NWI 2PG, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06415981
Lead sponsor
Invicta Medical Inc.
Collaborators
University College London Hospitals
Responsible party
Sponsor
First posted
May 16, 2024
Start date
Dec 21, 2022
Primary completion
Jun 2024 (estimated)
Completion
Jul 2024 (estimated)
Last update
May 16, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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