Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372847
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-03-25
Brief Title:
DISE-HNS Effect Study
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Assessment of the Effect of Hypoglossal Nerve Stimulation Therapy on the Site of Collapse During DISE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
DISE-HNS
Brief Summary:
The purpose of this study is to assess the site pattern and degree of upper airway collapse before and during hypoglossal nerve stimulation HNS treatment using clinical standard drug-induced sleep endoscopy DISE and using a novel non-invasive method predicting site of collapse from raw polysomnography PSG data
Furthermore outcomes will be compared between responders and non-responders
Furthermore outcomes will be compared between responders and non-responders
Detailed Description:
Patients who will receive hypoglossal nerve stimulation therapy will be recruited at the pre-operative consultation at the department of ENT As part of the standard procedure all patients who are eligible for HNS have already undergone DISE
To be included in the study the patient should have undergone or is scheduled to undergo a baseline PSG within two years of HNS implantation
All patients will undergo HNS-implantation and receive HNS-therapy as part of the standard pathway
One year after HNS-therapy patients will undergo another PSG as part of routine practice in these patients An additional DISE will be performed to assess the effect of HNS on the site pattern and degree of upper airway collapse
To be included in the study the patient should have undergone or is scheduled to undergo a baseline PSG within two years of HNS implantation
All patients will undergo HNS-implantation and receive HNS-therapy as part of the standard pathway
One year after HNS-therapy patients will undergo another PSG as part of routine practice in these patients An additional DISE will be performed to assess the effect of HNS on the site pattern and degree of upper airway collapse
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None