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Completed

NCT Number: NCT06283030

Evaluation of 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.

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorder Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt Bill Wilkerson Centre

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Hypoglossal Nerve Stimulation

Device

Device-mediated stimulation of the hypoglossal nerve

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Invicta Medical Inc.

Industry

Collaborators

  • Vanderbilt University Medical Center

Registry information

Official study title

Acute Proof-of-Concept Study to Evaluate Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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