RecruitingNot ApplicableNCT06520579

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

Sponsor

NYU Langone Health

Enrollment

50 participants

Start Date

Oct 15, 2024

Study Type

INTERVENTIONAL

Conditions

Dysphagia

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. .

Eligibility

Min Age: 21 YearsMax Age: 99 Years

Inclusion Criteria3

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 Criteria7

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.

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Interventions

BEHAVIORALProactive 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_SUPPLEMENTPremier 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.

BEHAVIORALHydration 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.