Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635265
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
A Study to Determine the Flow Changes Andor AHI Reduction When Stimulating Two Targets neural Andor Muscular for the Treatment of Obstructive Sleep Apnea in Adult Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Single Center Proof-of-Concept Study to Determine the Flow Changes Andor AHI Reduction When Stimulating Two Targets neural Andor Muscular for the Treatment of Obstructive Sleep Apnea in Adult Subjects
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Proof-of-Concept study will collect acute and sub-acute flow andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None