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

NCT ID: NCT06635265

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-03
• Study Completion Date: 2024-07-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Target stimulation

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Simulation of a combination of: HGN, AC, GG or strap muscles

Interventions

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

Simulation of a combination of: HGN, AC, GG or strap muscles

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hollywood Private Hospital

UNKNOWN

Sponsor Role: collaborator

Invicta Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Perth Head and Neck Surgery

Perth, Western Australia, Australia

Countries

Australia

Other Identifiers

IM_004

Identifier Type: -

Identifier Source: org_study_id