Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05914948
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-15
First Post:
2023-06-09
Brief Title:
Minimally Invasive Electrical Stimulation Of The Nerve Hypoglossal for the Treatment of Obstructive Sleep Apnea
Sponsor:
Capri Medical Limited
Organization:
Capri Medical Limited
Study Overview
Official Title:
Minimally Invasive Electrical Stimulation Of The Nerve Hypoglossal for the Treatment of Obstructive Sleep Apnea
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None