Actively Recruiting
Pilot Proof of Concept Study on Behavioral Intervention Effects on Swallowing and Voice After Anterior Cervical Discectomy and Fusion Surgery
Led by NYU Langone Health · Updated on 2026-02-27
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a behavioral health program can improve swallowing and voice outcomes in patients undergoing Anterior Cervical Discectomy and Fusion (ACDF) surgery. This prospective study enrolls patients having primary ACDF surgery and aims to determine if the program helps prevent swallowing and voice difficulties six weeks after surgery. The research is conducted at NYU Langone and focuses on dysphagia, which affects swallowing ability. Participants will receive a behavioral intervention program including hydration counseling, protein supplementation, and daily pharyngeal/laryngeal exercises for seven weeks total. This begins one week before surgery and continues for six weeks afterward. Weekly 45-minute sessions with a speech-language pathologist start about one week post-surgery and last for six weeks. The study compares these patients to historical controls who had ACDF surgery but did not receive the intervention. During the study, participants will undergo swallowing assessments using videofluoroscopy before surgery and six weeks after. Acoustic voice samples and patient-reported measures for swallowing and voice will also be collected at these times. Researchers will track adherence to hydration goals via a daily log. The main outcomes measured include changes in swallowing function and voice quality from baseline to six weeks post-operation. The total study duration for each participant is seven weeks.
CONDITIONS
Brief Title
Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to sign consent form to participate in the study.
- Age between 21 and 99 years.
- Scheduled to undergo ACDF surgery with surgeons in the departments of Neurosurgery or Orthopedic Surgery at NYU Langone.
You will not qualify if you...
- Patients with non-degenerative spine conditions, such as trauma, tumors, infection, radiation, and diabetes.
- Patients with prior posterior-approach cervical spine procedures.
- Patients undergoing ACDF revision procedures.
- 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.
- Pregnancy. Female subjects must confirm they are not pregnant before enrolling in the study.
- Patients with chronic kidney disease, limiting their ability to consume high levels of protein.
- Patients with known allergies to ingredients listed in Premier Protein Clear drinks.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 weeks
Participants begin daily proactive pharyngeal-laryngeal exercises one week prior to surgery and continue daily exercises for 6 weeks after surgery. They also receive hydration counseling with daily tracking and consume a daily protein supplement for 7 weeks.
Weekly visits with a speech-language pathologist for approximately 6 weeks starting one week post surgery
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
S
Sonja Molfenter, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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