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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
20
Subjects meeting study eligibility criteria will be implanted with a Medtronic 8-contact Vectris subcompact or compact electrode.
Clínica de Otorrinolaringología de Antioquia (ORLANT)
Medellín, Antioquia, Colombia
Apnea-Hypopnea Index (AHI)
Demonstrate an AHI reduction from baseline of 50% and an AHI less than 20 on follow-up polysomnography
Time frame: 6 months
Oxygen Desaturation Index (ODI)
Demonstrate at least a 25% reduction in the ODI from the initial value.
Time frame: 6 months
Security
The primary safety objective is to assess the incidence of events Adverse events related to the device and the insertion technique
Time frame: 6 months
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