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
NYU Langone Health
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
- Age range
- 21–99 years
- Sex
- All
- Healthy volunteers
- No
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, hea…
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.
Location
- NYU Langone HealthNew York, New York