Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627127
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-24
Brief Title:
A Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets neural Andor Muscular for the Treatment of Obstructive Sleep Apnea
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicenter Proof-of-Concept Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets neural Andor Muscular for the Treatment of Obstructive Sleep Apnea
Status:
RECRUITING
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 is to collect acute and short-term sub-acute if applicable changes in respiratory parameters following the percutaneous placement of electrode arrays Acute placement and data collection will be conducted while performing a Drug Induced Sleep Endoscopy DISE where the goal will be to quantify changes in airflow with stimulation Data will also be collected during a one- or two-night polysomnography PSG to investigate airflow and sleep stability responses with and without different levels of stimulation during sleep Where feasible OSA severity data will be collected as measured via the apneahypopnea index AHI with stimulation versus without stimulation as a secondary objective Both data collections will be done when stimulating the hypoglossal nerve HGN or Genioglossus muscle GG and a second functional target Ansa Cervicalis - AC or the strap muscles sternohyoid and sternothyroid with a set of electrode arrays either in combination or separately
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