Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520579
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Anterior Cervical Discectomy and Fusion ACDF - Behavioral Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Proof of Concept Prospective Cohort Single-Center Study on the Effects of Behavioral Intervention on Swallowing and Voice Outcomes After Anterior Cervical Discectomy and Fusion ACDF Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 study will prospectively recruit and enroll patients undergoing primary Anterior Cervical Discectomy and Fusion ACDF surgeries at NYU Langone Participants will undergo pre-operative and six-week post-operative swallowing assessment using videofluoroscopy VFSS Acoustic voice samples and Patient Reported Outcome Measures PROMs for swallowing and voice will also be collected Beginning one-week before surgery participants will begin a behavioral health program that will be continued for six-weeks after surgery The primary goal of this study will be to determine whether a preventative behavioral health program improves instrumental measures of swallowing and voice six-weeks after ACDF surgery
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