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

Not Applicable

Completed

• Conditions: Sleep Apnea; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Sleep Disorder
• Interventions: Device: Target Stimulation (HGN, AC, GG, Strap muscles)

• Registration Number: NCT06635265
• Lead Sponsor: Invicta Medical Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-03
• Primary Completion: 2024-06-28
• Study Completion: 2024-07-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Study First Posted: 2024-10-10
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

A patient 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) < 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.

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Target stimulation	Target Stimulation (HGN, AC, GG, Strap muscles)	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.

Primary Outcome Measures

Name	Time	Method
Impacts on acute airway opening	Day 0 to 3	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).
Impacts on airflow during a acute assessment	Day 0 to 3	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.

Secondary Outcome Measures

Name	Time	Method
Impacts on airway opening during a sub-acute assessment	Day 0 to 3	Demonstration of sub-acute flow increase and/or AHI reduction when stimulating two targets simultaneously during natural sleep as measured with polysomnography (PSG), measured by polysomnography.

Trial Locations

Locations (1)

Perth Head and Neck Surgery; 🇦🇺 Perth, Western Australia, Australia