NCT06520579

Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention

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: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

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. .

Conditions

• Dysphagia

Interventions

Type	Name	Description
BEHAVIORAL	Proactive pharyngeal-laryngeal Exercise Program	This program consists of daily proactive pharyngeal-laryngeal exercises and weekly sessions with a speech-language pathologist post surgery. One week prior to surgery participants will begin daily proactive pharyngeal-laryngeal exercises and continue these daily exercises for 6 weeks post surgery. Beginning approximately one week after surgery, participants will meet with the speech-language pathologist. Sessions will occur weekly, for approximately 6 weeks, and will last approximately 45 minutes.
DIETARY_SUPPLEMENT	Premier Protein Clear ® High Protein	Premier Protein Clear ® High Protein (20 grams of protein and 90 calories per 16.9 oz. drink) 1 drink daily for 7 weeks.
BEHAVIORAL	Hydration Counseling	Daily hydration goals are based on recommended guidelines for adults, by gender, from The United States National Academy of Medicine (US NAM) and the European Food Safety Authority (ESFA) (\~2.0 L/day for women; \~2.5 L/day for men of fluid intake, accounting for 20% daily fluid intake from food sources). Patients will be required to track via paper log whether they met their hydration goals daily.

Timeline

• Start date: 2024-10-15
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-07-25
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States