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. .
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
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 (20 grams of protein and 90 calories per 16.9 oz. drink) 1 drink daily for 7 weeks.
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.
NYU Langone Health
New York, New York, United States
RECRUITINGChange in pharyngeal constriction
Outcome measure will be assessed using 2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention
Time frame: 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
Time frame: 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.
Time frame: Baseline, 6 weeks post-op
Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Ratings
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.
Time frame: Baseline, 6 weeks post-op
Change in Dysphonia 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, 11 ask about speaking functions using a 5-point scoring method (1-5). Scores range from 11-55, where lower scores indicate dysphonia.
Time frame: Baseline, 6 weeks post-op
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