Behavioral intervention for swallowing improvement after neck surgery
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
NA · NYU Langone Health · NCT06520579
This study is testing if a special program to help with swallowing can improve recovery for people having neck surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | NYU Langone Health (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06520579 on ClinicalTrials.gov |
What this trial studies
This study aims to recruit patients undergoing Anterior Cervical Discectomy and Fusion (ACDF) surgeries at NYU Langone Health. Participants will undergo swallowing assessments before and six weeks after surgery, alongside a behavioral health program that starts one week prior to surgery and continues for six weeks post-operation. The study will evaluate whether this proactive approach enhances swallowing and voice outcomes after the surgical procedure. Various assessments, including videofluoroscopy and patient-reported outcomes, will be utilized to measure effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-99 scheduled for ACDF surgery at NYU Langone Health.
Not a fit: Patients with non-degenerative spine conditions or pre-existing dysphagia due to neurological issues or cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve swallowing and voice quality for patients recovering from ACDF surgery.
How similar studies have performed: While similar behavioral interventions have shown promise in other contexts, this specific approach in the ACDF population is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Sonja Molfenter, PhD — NYU Langone Health
- Study coordinator: Sonja Molfenter, PhD
- Email: Smm16@nyu.edu
- Phone: 212-992-7694
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dysphagia