Trials / Recruiting
RecruitingNCT06627127
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
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- Sponsor
- Invicta Medical Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Target stimulation (HGN, AC, GG, Strap muscles) | Stimulation of the HGN or GG along with AC or strap muscles. |
Timeline
- Start date
- 2023-11-01
- Primary completion
- 2024-11-01
- Completion
- 2024-11-01
- First posted
- 2024-10-04
- Last updated
- 2024-10-04
Locations
4 sites across 1 country: Australia
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06627127. Inclusion in this directory is not an endorsement.