Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Disorder; Sleep Apnea
• Intervention / Treatment: Device: Hypoglossal nerve stimulation

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Bill Wilkerson Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypoglossal nerve stimulation	Device: Hypoglossal nerve stimulation; Device-mediated stimulation of the hypoglossal nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Invicta Medical Inc.
• Collaborators: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): September 25, 2023
• Study Completion (Actual): September 25, 2023

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders; Apnea
• Other Study ID Numbers: IM-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes