Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention

NCT06520579 | Recruiting

• 1 other identifier: 24-00667
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. .

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (3)

• Change in pharyngeal constriction

  Outcome measure will be assessed using 2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention

  Baseline, 6 weeks post-op

• Change in pharyngeal shortening

  Outcome measure will be assessed using 2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention

  Baseline, 6 weeks post-op

• Change in Dysphagia Score measured by The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI)

  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.

  Baseline, 6 weeks post-op

Secondary Outcomes (2)

• Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Ratings

  Baseline, 6 weeks post-op

• Change in Dysphonia Score measured by The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI)

  Baseline, 6 weeks post-op

Study Arms (2)

Proactive Behavioral Intervention coupled with protein supplementation

EXPERIMENTAL

Patients will receive the behavioral intervention program comprised of hydration counseling, protein supplementation, and daily pharyngeal/laryngeal exercise for a total of 7 weeks.

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

Historical Control Group

NO INTERVENTION

Historical control data from subjects who underwent Anterior Cervical Discectomy and Fusion (ACDF) surgery but did not receive any behavioral intervention.

Interventions

Proactive pharyngeal-laryngeal Exercise Program BEHAVIORAL

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.

Proactive Behavioral Intervention coupled with protein supplementation

Premier Protein Clear ® High Protein DIETARY_SUPPLEMENT

Premier Protein Clear ® High Protein (20 grams of protein and 90 calories per 16.9 oz. drink) 1 drink daily for 7 weeks.

Proactive Behavioral Intervention coupled with protein supplementation

Hydration Counseling BEHAVIORAL

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.

Proactive Behavioral Intervention coupled with protein supplementation

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Sonja Molfenter, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonja Molfenter, PhD

CONTACT

212-992-7694; Smm16@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 25, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to smm16@nyu.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)