NCT06283017

Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

Acute Proof-of-Concept Study to Evaluate Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Invicta Medical Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed.

Conditions

• Sleep Apnea
• Sleep Apnea, Obstructive
• Sleep Disorder
• Sleep Apnea Syndromes

Interventions

Type	Name	Description
DEVICE	Hypoglossal nerve stimulation	Device stimulation of the hypoglossal nerve

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2024-02-28
• Last updated: 2024-03-13

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated device study