A Study to Determine the Flow Changes And/or AHI Reduction When Stimulating Two Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea in Adult Subjects

NCT06635265 | Completed DMC FDA Device

• 1 other identifier: IM_004
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This Proof-of-Concept study will collect acute and sub-acute flow and/or AHI data following the placement of lead arrays under direct vision. The acute placement and data collection will be collected following the completion of the pre-scheduled neck dissection surgery. The sub-acute data will be collected in a sleep lab during a polysomnography (PSG). Both data collections will be done when stimulating (using an external pulse generator) the hypoglossal nerve or Genioglossus muscle (GG) and a second neural target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid) with a set of Off-the-Shelf (OTS) electrode arrays.

Conditions

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

Keywords

Sleep Apnea device

Outcome Measures

Primary Outcomes (2)

• Impacts on acute airway opening

  Demonstration of acute airway opening as visually observed under nasoendoscopy when stimulating the HGN or GG and a second target (neural or direct muscle stimulation).

  Day 0 to 3

• Impacts on airflow during a acute assessment

  Acute increase in airflow when stimulating the HGN or GG and a second target (neural or direct muscle stimulation), measured by changes in amplitude (mA) during target stimulation.

  Day 0 to 3

Secondary Outcomes (1)

• Impacts on airway opening during a sub-acute assessment

  Day 0 to 3

Study Arms (1)

Target stimulation

EXPERIMENTAL

Stimulation of a combination of targets: Hypoglossal nerve (HGN) and Ansa Cervicalis (AC), Genioglossus (GG) and AC, HGN and strap muscles, or GG and strap muscles, during an acute and sub-acute phase.

Device: Target Stimulation (HGN, AC, GG, Strap muscles)

Interventions

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

Simulation of a combination of: HGN, AC, GG 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) \< 38 kg/m2.
• Subject must be eligible for neck dissection surgery.
• Written informed consent obtained from the patient 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:

• Patients 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.
• Significant tongue weakness.
• Aerodigestive tract tumor or reconstructive surgery performed at the same time as neck dissection.
• Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia 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, or
• 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.
• Concomitant oral or pharyngeal surgery.

Sponsors & Collaborators

• Invicta Medical Inc.: lead
• Hollywood Private Hospital: collaborator

Study Sites (1)

Perth Head and Neck Surgery

Perth, Western Australia, 6009, 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

Model Details: Electrode arrays placed adjacent to nerves are connected to an external pulse generator to evaluate the effect of short-term stimulation on airflow and/or AHI

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 10, 2024
• Study Start: April 3, 2023
• Primary Completion: June 28, 2024
• Study Completion: July 1, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)