NCT06635265

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

Single Center Proof-of-Concept 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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Invicta Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Target Stimulation (HGN, AC, GG, Strap muscles)	Simulation of a combination of: HGN, AC, GG or strap muscles

Timeline

• Start date: 2023-04-03
• Primary completion: 2024-06-28
• Completion: 2024-07-01
• First posted: 2024-10-10
• Last updated: 2024-10-10

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated device study