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RECRUITING
NCT06627127
NA

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

Sponsor: Invicta Medical Inc.

View on ClinicalTrials.gov

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.

Official title: Multicenter Proof-of-Concept Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2023-11-01

Completion Date

2024-11

Last Updated

2024-10-04

Healthy Volunteers

No

Interventions

DEVICE

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

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

Locations (4)

Illawara ENT

Wollongong, New South Wales, Australia

Complete ENT

Brisbane, Queensland, Australia

Adelaide Institute for Sleep Health, Flinders University

Adelaide, South Australia, Australia

Perth Head and Neck Surgery

Perth, Western Australia, Australia