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

NCT06627127 | Recruiting DMC FDA Device

• 1 other identifier: IM-005
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

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

Keywords

Sleep Apnea device

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Acute increase in airflow measured during target stimulation

  Day 0 to 3

• Assessment of acute airway opening during target stimulation

  Day 0 to 3

• Assessment of sub-acute airflow increase and/or AHI reduction during target stimulation during a sleep study.

  Day 0 to 3

Study Arms (1)

Target stimulation

EXPERIMENTAL

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)

Interventions

Target stimulation (HGN, AC, GG, Strap muscles) DEVICE

Stimulation of the HGN or GG along with AC or strap muscles.

Target stimulation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Invicta Medical Inc.: lead
• Adelaide Institute for Sleep Health: collaborator
• The University of Western Australia: collaborator
• Flinders University: collaborator

Study Sites (4)

Illawara ENT

Wollongong, New South Wales, 2500, Australia

RECRUITING

Complete ENT

Brisbane, Queensland, 4000, Australia

NOT YET RECRUITING

Adelaide Institute for Sleep Health, Flinders University

Adelaide, South Australia, 5042, Australia

RECRUITING

Perth Head and Neck Surgery

Perth, Western Australia, 6009, Australia

RECRUITING

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

Central Study Contacts

Tim Fayram, MS

CONTACT

+1 4086127570; tfayram@invictamedical.com

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

Model Details: Multicenter, proof- of-concept (POC) study. Electrode arrays percutaneously placed under ultrasound adjacent to nerves, connected to an external pulse generator will be used to evaluate the combined effect of short-term stimulation on airflow and/or AHI.

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: October 4, 2024
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)