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NCT Number: NCT06520579

Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention

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. .

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Change in pharyngeal constriction

    Time frame: 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

  2. Change in pharyngeal shortening

    Time frame: 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

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sonja Molfenter, PhD

CONTACT

[email protected]

212-992-7694

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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