A Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (Neural and/or Muscular) for the Treatment of Obstructive Sleep Apnea

Multicenter Proof-of-Concept Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (Neural and/or Muscular) for the Treatment of Obstructive Sleep Apnea

This proof-of-concept study is to collect acute and short-term sub-acute (if applicable) changes in respiratory parameters following the percutaneous placement of electrode arrays. Acute placement and data collection will be conducted while performing a Drug Induced Sleep Endoscopy (DISE) where the goal will be to quantify changes in airflow with stimulation. Data will also be collected during a one- or two-night polysomnography (PSG) to investigate airflow and sleep stability responses with and without different levels of stimulation during sleep. Where feasible, OSA severity data will be collected, as measured via the apnea/hypopnea index (AHI) with stimulation versus without stimulation as a secondary objective. Both data collections will be done when stimulating the hypoglossal nerve (HGN) or Genioglossus muscle (GG) and a second functional target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid) with a set of electrode arrays either in combination or separately.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Disorder; Sleep Apnea
• Intervention / Treatment: Device: Target stimulation (HGN, AC, GG, Strap muscles)

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Wollongong, New South Wales, Australia, 2500
      • Illawara ENT
  • Queensland
    • Brisbane, Queensland, Australia, 4000
      • Complete ENT
  • South Australia
    • Adelaide, South Australia, Australia, 5042
      • Adelaide Institute for Sleep Health, Flinders University
  • Western Australia
    • Perth, Western Australia, Australia, 6009
      • Perth Head and Neck Surgery

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

A subject must meet all of the following inclusion criteria to be eligible for inclusion in this study:

• Age above 18 years not under guardianship, under curatorship or under judicial protection.
• Body Mass Index (BMI) < 35 kg/m2.
• OSA (15 < AHI < 80 events/h sleep) documented by a sleep study performed during the past 24 months in the absence of any major weight change or other medical issues.
• Subject must be eligible for a diagnostic DISE or surgical procedure (acute study measures only).
• Written informed consent obtained from the subject prior to performing any study specific procedure.
• Willing and capable to comply with all study requirements, including specific lifestyle considerations, evaluation procedures and questionnaires for the whole duration of the trial.

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from participation in this study:

• Major anatomical or functional abnormalities that would impair the ability of the electrode arrays to be positioned.
• Significant comorbidities that contraindicate surgery or general anesthesia/DISE
• Significant tongue weakness
• Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia/DISE in the judgment of the investigator.

• Prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems:

  • Airway cancer surgery or radiation,
  • Mandible or maxilla surgery in the previous 3 years (not counting dental treatments),
• Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery),
• Prior hypoglossal nerve stimulation device implantation.
• 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: Target stimulation; Stimulation of the Hypoglossal nerve (HGN) or Genioglossus muscle (GG) and a second functional target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid).	Device: Target stimulation (HGN, AC, GG, Strap muscles); Stimulation of the HGN or GG along with AC or strap muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of technical delivery in stimulating target nerves or muscles	Assessment of the technical ability to simulate the target nerves and/or muscles as observed during nasoendoscopy and ultrasound imaging	Day 0 to 3
Assessment of the required stimulation amplitude	Assess the required stimulation amplitude measured in milliamps (mA) to improve airflow during stimulation as assessed by direct visualisation of the amplitude.	Day 0 to 3
Feasibility of participant recruitment and retention	Demonstration of participant recruitment and retention rates for a POC target stimulation in OSA participant study, measured by direct participant recruitment numbers and during on study.	Day 0 to 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute increase in airflow measured during target stimulation	Demonstration of acute increase in airflow when stimulating the HGN or GG in combination with the AC or strap muscles during a flow limited event (hypopnea or apnea), measured in liters per second (L/s) using pneumotachometer.	Day 0 to 3
Assessment of acute airway opening during target stimulation	Demonstration of changes in acute cross-sectional airway opening measured under nasoendoscopy when stimulating two functional targets simultaneously (i.e., the HGN and AC). Video imaging and physician interpretation of nasoendoscopic images will be used to review outcome measures.	Day 0 to 3
Assessment of sub-acute airflow increase and/or AHI reduction during target stimulation during a sleep study.	Demonstration of in sub-acute flow increase and/or AHI reduction when stimulating two functional targets simultaneously during sleep as measured with polysomnography (PSG), measured in liters per second (L/s) using pneumotachometer.	Day 0 to 3

Collaborators and Investigators

• Sponsor: Invicta Medical Inc.
• Collaborators: Flinders University; Adelaide Institute for Sleep Health; The University of Western Australia

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Actual): January 20, 2025
• Study Completion (Actual): January 20, 2025

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Sleep Apnea device
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Respiratory Tract Diseases; Respiration Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders
• Other Study ID Numbers: IM-005

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