Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention

Not Applicable

Recruiting

• Conditions: Dysphagia
• Interventions: Behavioral: Proactive pharyngeal-laryngeal Exercise Program; Dietary Supplement: Premier Protein Clear ® High Protein; Behavioral: Hydration Counseling

• Registration Number: NCT06520579
• Lead Sponsor: NYU Langone Health

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

Not available

Study Timeline

• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-25
• Study Start: 2024-10-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Able and willing to sign consent form to participate in the study.
2. Age between 21- 99 years.
3. Scheduled to undergo ACDF surgery with surgeons in the departments of Neurosurgery or Orthopedic Surgery at NYU Langone.

Exclusion Criteria

1. Patients with non-degenerative spine conditions, such as trauma, tumors, infection, radiation, and diabetes.
2. Patients with prior posterior-approach cervical spine procedures.
3. Patients undergoing ACDF revision procedures.
4. Patients who report a pre-existing dysphagia as the result of a neurological deficit or disorder, head and neck cancer treatment, and/or muscular condition.
5. Pregnancy. Female subjects must confirm they are not pregnant before enrolling in the study.
6. Patients with chronic kidney disease, limiting their ability to consume high levels of protein.
7. Patients with known allergies to ingredients listed in Premier Protein Clear drinks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proactive Behavioral Intervention coupled with protein supplementation	Hydration Counseling	Patients will receive the behavioral intervention program comprised of hydration counseling, protein supplementation, and daily pharyngeal/laryngeal exercise for a total of 7 weeks.
Proactive Behavioral Intervention coupled with protein supplementation	Premier Protein Clear ® High Protein	Patients will receive the behavioral intervention program comprised of hydration counseling, protein supplementation, and daily pharyngeal/laryngeal exercise for a total of 7 weeks.
Proactive Behavioral Intervention coupled with protein supplementation	Proactive pharyngeal-laryngeal Exercise Program	Patients will receive the behavioral intervention program comprised of hydration counseling, protein supplementation, and daily pharyngeal/laryngeal exercise for a total of 7 weeks.

Primary Outcome Measures

Name	Time	Method
Change in pharyngeal constriction	Baseline, 6 weeks post-op	Outcome measure will be assessed using 2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention
Change in Dysphagia Score measured by The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI)	Baseline, 6 weeks post-op	The HSS-DDI consists of 31 patient-reported questions to assess Dysphagia and Dysphonia. Of the 31 questions, 20 ask about swallowing using a 5-point scoring method (1-5). Scores range from 20-100, where lower scores indicate dysphagia.
Change in pharyngeal shortening	Baseline, 6 weeks post-op	Outcome measure will be assessed using 2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention

Secondary Outcome Measures

Name	Time	Method
Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Ratings	Baseline, 6 weeks post-op	Complete acoustic sound files will be blindly rated using the Consensus for Auditory Perceptual Evaluation of Voice (CAPE-V), a validated quantitative rating tool used for perceptual analysis of voice. It is intended to describe the severity of various auditory attributes of a voice problem. The CAPE-V is a visual analog scale that numerically rates various vocal qualities along a continuum from 0-100 based on what the experienced listener hears, with higher values indicating worse severity.
Change in Dysphonia Score measured by The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI)	Baseline, 6 weeks post-op	The HSS-DDI consists of 31 patient-reported questions to assess Dysphagia and Dysphonia. Of the 31 questions, 11 ask about speaking functions using a 5-point scoring method (1-5). Scores range from 11-55, where lower scores indicate dysphonia.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States