Evaluation of the Effects 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: Active, not recruiting
• 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

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5042
      • Adelaide Institute for Sleep Health, Flinders University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Subject must be eligible for a diagnostic or surgical procedure and

• Suffers from OSA (apnea/hypopnea index >10 event/h sleep) based on history and a physical exam.
• Is a surgical candidate.
• Is willing and capable of providing informed consent.
• Is willing to have a representative electrode array temporarily placed in the submandibular and mylohyoid space.
• Is willing to participate in the designated follow-up visits.
• Must be in good general health.
• 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.
• Must be minimum of 18 years and maximum 80 years of age.

Exclusion Criteria:

• Has Body Mass Index above 35 kg/m2.
• Has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
• Has significant co-morbidities making them unable or inappropriate to participate in this POC study.

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-mediated stimulation of the hypoglossal nerve	Device: Hypoglossal nerve stimulation; Device stimulation of the hypoglossal nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tongue protrusion outcomes	Visual verification of protrusion of the tongue during stimulation at the target stimulation location with a representative electrode array.	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
Target identification and access outcomes	Identification of and access to the target stimulation location aligned with the medial branch of the Hypoglossal Nerve	Day 0
Characterization of lead placement 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
Lead placement and removal outcomes	To demonstrate the ability to safely place and remove the electrode array, per protocol instructions.	Day 0

Collaborators and Investigators

• Sponsor: Invicta Medical Inc.
• Collaborators: Adelaide Institute for Sleep Health, Flinders University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

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 13, 2024
• Last Update Submitted That Met QC Criteria: March 10, 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-002

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
• product manufactured in and exported from the U.S.: Yes