Recruiting

ACDF

Sponsor:

NYU Langone Health

Code:

NCT06520579

Conditions

Dysphagia

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Proactive pharyngeal-laryngeal Exercise Program

Premier Protein Clear ® High Protein

Hydration Counseling

Study Details

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

Study ID

NCT06520579

Start date

Oct 15, 2024

Status verified date

Feb, 2026

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Proactive Behavioral Intervention coupled with protein supplementation

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

no intervention: Historical Control Group

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

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

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

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 outcome measure

  • Change in pharyngeal constriction [ Time Frame: Baseline, 6 weeks post-op ]
  • Change in pharyngeal shortening [ Time Frame: Baseline, 6 weeks post-op ]
  • Change in Dysphagia Score measured by The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI) [ Time Frame: Baseline, 6 weeks post-op ]

Central Contacts and Locations

Central contacts

Sonja Molfenter, PhD

212-992-7694Smm16@nyu.edu

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-02-27.