Investigators in NYU Langone’s Department of Otolaryngology—Head and Neck Surgery are committed to advancing the field with groundbreaking clinical research on cochlear and auditory brainstem implants and vocal fold scarring.

As active participants in clinical research, we offer our patients the latest treatments and therapies for hearing loss and voice disorders. Our faculty members regularly share research findings at national and international conferences and in peer-reviewed medical journals.

Current Clinical Trials

The following clinical trials are underway at in the Department of Otolaryngology—Head and Neck Surgery.

A Phase II Open-Label Randomized Controlled Study of PDR001 in Patients with Moderately Differentiated/Undifferentiated Locally Advanced Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Who Progressed on Standard Treatment
Investigator: Zujun Li, MD

A Prospective Multi-Site Trial of a Point of Care Saliva-Based Detection Test Based
on Soluble CD44 (OncAlert) for Presence of Disease in Previously Untreated Oral Cavity and Oropharynx Squamous Cell Carcinoma
Investigator: Brian L. Schmidt, MD, PhD, DDS

Auditory Brainstem Implant (ABI) in Children with No Cochleae or Auditory Nerves
Investigators: J. Thomas Roland Jr., MD, and Susan B. Waltzman, PhD

Cochlear Implantation in Adults with Asymmetric Hearing Loss Clinical Trial
Investigator: Susan B. Waltzman, PhD

High-Intensity Group Vocal Exercise to Improve Laryngeal Function in Patients with Parkinson’s Disease
Investigator: Aaron M. Johnson, PhD

Investigation of Human Laryngeal Evoked Brainstem Potentials
Investigator: Milan R. Amin, MD

Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes
Investigator: Milan R. Amin, MD

Observational Study of Dental Outcomes in Head and Neck Cancer Patients (ORARAD)
Investigator: Brian L. Schmidt, MD, PhD, DDS

Phase II: Adaptive De-Escalation of Radiation Therapy Dose in Favorable Risk HPV-Positive Oropharyngeal Carcinoma (ART)
Investigators: Milan R. Amin, MD; Mark D. DeLacure, MD; Adam S. Jacobson, MD; Mark S. Persky, MD

Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)
Investigator: Kenneth S. Hu, MD

Study to Compare Avelumab in Combination with Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck (JAVELIN HEAD AND NECK 100)
Investigator: Zujun Li, MD

1456GCC A Phase II Trial of Reirradiation Combined with Open-Label MK-3475 (Pembrolizumab) in Patients with Locoregional Inoperable Recurrence or Second Primary Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Investigator: Zujun Li, MD

Clinical Outcomes Research

Faculty, residents, and medical students in the Department of Otolaryngology—Head and Neck Surgery have several additional ongoing clinical outcomes research projects underway.

Our current initiatives include the following:

• examining quality-of-life changes among children who receive auditory brainstem implants, including case studies of children with a cochlear implant in one ear and an auditory brainstem implant in the other
• studying the effect of later-diagnosed disabilities on cochlear implant performance among children who received implants before 12 months of age
• assessing barriers to cochlear implantation among low-income families
• determining causal factors for operating room infections during cochlear implant surgery
• analyzing the epidemiological characteristics of patients with recurrent vocal fold leukoplakia
• conducting cost analyses of radiotherapy versus microlaryngeal surgery for early glottic cancer and channeled, distal chip laryngoscope for in-office laryngopharyngeal biopsies
• examining variability on the Voice Handicap Index-10 over time

For more information about clinical trials and clinical outcomes research, contact Kristin Montella, division administrator, research, and academic operations, at kristin.montella@nyulangone.org or 212-263-8182.