NCT05914948

Minimally Invasive Electrical Stimulation Of The Nerve Hypoglossal for the Treatment of Obstructive Sleep Apnea

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Capri Medical Limited · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Minimally invasive electrical stimulation of the nerve hypoglossal for the treatment of obstructive sleep apnea. To demonstrate the correct stimulation of the medial branches of the hypoglossal nerve and tongue protrusion using a minimally invasive implantation technique in patients with OSA.

Detailed description

Study title: Minimally invasive electrical stimulation of the nerve hypoglossal for treatment for obstructive sleep apnea. Study device: Medtronic 8-contact Vectris subcompact or compact electrode. Study design: This is an initial feasibility study that seeks to determine the safety and effectiveness of a minimally invasive technique to implant a hypoglossal nerve stimulation electrode in patients with obstructive sleep apnea. Subjects meeting study eligibility criteria will be implanted with a Medtronic 8-contact Vectris subcompact or compact electrode. In the follow-up visits, quality of life and sleepiness scales (Epworth) will be performed, and on days 4 and 7 a control polysomnography. All results will be compared with the baseline data obtained at the start of the study. Study Size: Up to 30 subjects may be enrolled to achieve a number of implanted subjects between 10 to 20. Study Duration: Total expected duration per subject is approximately 10 days. The study is estimated to take 6 months. Objective of the study: The main objective is to evaluate the safety and effectiveness of a minimally invasive technique to implant a hypoglossal nerve stimulation electrode in patients with obstructive sleep apnea.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Medtronic 8-contact Vectris subcompact or compact electrode.	Subjects meeting study eligibility criteria will be implanted with a Medtronic 8-contact Vectris subcompact or compact electrode.

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-11-01
• Completion: 2025-05-01
• First posted: 2023-06-22
• Last updated: 2024-02-15

Locations

1 site across 1 country: Colombia

Regulatory

• FDA-regulated device study