Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

NCT06283030 | Completed DMC FDA Device

• 1 other identifier: IM-001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sleep Apnea; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Sleep Disorder

Outcome Measures

Primary Outcomes (5)

• 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.

  Day 0

• Tongue protrusion outcomes

  Visual verification of protrusion of the tongue during stimulation at the target stimulation location with a representative electrode array.

  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.

  Day 0

• Electrode array placement and removal outcomes

  To demonstrate the ability to safely place and remove the electrode array, per protocol instructions.

  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

  Day 30

Study Arms (1)

Hypoglossal nerve stimulation

EXPERIMENTAL

Device: Hypoglossal nerve stimulation

Interventions

Hypoglossal nerve stimulation DEVICE

Device-mediated stimulation of the hypoglossal nerve

Hypoglossal nerve stimulation

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Invicta Medical Inc.: lead
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

Vanderbilt Bill Wilkerson Centre

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 28, 2024
• Study Start: December 1, 2021
• Primary Completion: September 25, 2023
• Study Completion: September 25, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)