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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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-10-04

No results posted yet for this study

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

Interventions

DEVICE

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

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

Sponsors & Collaborators

  • Adelaide Institute for Sleep Health

    collaborator OTHER

  • The University of Western Australia

    collaborator OTHER

  • Flinders University

    collaborator OTHER

  • Invicta Medical Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-11-30
Completion
2024-11-30
FDA Device
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06627127 on ClinicalTrials.gov