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

NCT ID: NCT06627127

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-11-30

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

Study Design

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

Study Groups

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).

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Interventions

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

Stimulation of the HGN or GG along with AC 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) < 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

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

Sponsors

Adelaide Institute for Sleep Health

OTHER

Sponsor Role: collaborator

The University of Western Australia

OTHER

Sponsor Role: collaborator

Flinders University

OTHER

Sponsor Role: collaborator

Invicta Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Illawara ENT

Wollongong, New South Wales, Australia

Site Status: RECRUITING

Complete ENT

Brisbane, Queensland, Australia

Site Status: NOT_YET_RECRUITING

Adelaide Institute for Sleep Health, Flinders University

Adelaide, South Australia, Australia

Site Status: RECRUITING

Perth Head and Neck Surgery

Perth, Western Australia, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Tim Fayram, MS

Role: CONTACT

tfayram@invictamedical.com

+1 4086127570

Facility Contacts

Tim Fayram, MS

Role: primary

Tim Fayram, MS

Role: primary

Tim Fayram, MS

Role: primary

Tim Fayram, MS

Role: primary

Other Identifiers

IM-005

Identifier Type: -

Identifier Source: org_study_id