Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

NCT06283017 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IM-002
• 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 Disorder; Sleep Apnea Syndromes

Outcome Measures

Primary Outcomes (5)

• 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

• 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 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

• 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-mediated stimulation of the hypoglossal nerve

Device: Hypoglossal nerve stimulation

Interventions

Hypoglossal nerve stimulation DEVICE

Device stimulation of the hypoglossal nerve

Hypoglossal nerve stimulation

Eligibility Criteria

• Age: 18 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Invicta Medical Inc.: lead
• Adelaide Institute for Sleep Health, Flinders University: collaborator

Study Sites (1)

Adelaide Institute for Sleep Health, Flinders University

Adelaide, South Australia, 5042, Australia

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: June 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)