New Clinical Trial Grant Awarded to USF Inter-Collegiate Team
The challenges of preventing or treating age-related hearing loss (ARHL- presbycusis) share similarities with the other top two chronic medical conditions of our rapidly expanding aged population: cardiovascular disease and arthritis; costing billions of dollars annually.
ARHL: Number 1 communication disorder and top neurodegenerative condition of our aged population. Severity recently linked to earlier onset of dementia. The most common compliant from individuals with ARHL is difficulty hearing speech in background noise listening conditions, e.g. cocktail party.
The negative impact of ARHL on the quality of life in our seniors warrants identifying novel interventions; as there are no FDA-approved medical treatments for permanent hearing loss, including ARHL, despite prevalence of over 10% of our population, over 40 million people in the US alone.
An innovative team of researchers and clinicians at the University of South Florida have just been awarded a $400,000, year-long Clinical Trial grant to test the first drug in the world to advance to Phase 2 Clinical Trials for treating ARHL.
The USF team consists of:
- Dr. Robert Frisina,Principal Investigator; Professor of Chemical & Biomedical Engineering and Communication Sciences & Disorders; Biomedical Engineering Director; and Director of the USF Global Center for Hearing & Speech Research (www.gchsr.usf.edu); College of Engineering
- Dr. Victoria Williams-Sanchez,Co-Investigator and Chief Coordinator of the Auditory Rehabilitation & Clinical Trials Laboratory; Research Assistant Professor of Communication Sciences & Disorders; College of Behavioral & Community Sciences
- Dr. Terry Chisolm,Co-Investigator; Vice Provost and Professor of Communication Sciences & Disorders; College of Behavioral & Community Sciences
- Dr. Paul Boyev, Medical Director & Co-Investigator; Assoc. Professor of Otolaryngology and Head & Neck Surgery, Division Chief, Medicine/Otolaryngology; College of Medicine, USF Health
- Our Students in Communication Sciences & Disorders:
- Amanda Brandino, AuD- Graduate doctoral program
- Celia D. Riffel, AuD- Graduate doctoral program
- Laura Westermann, BA- Undergraduate
This Clinical Trial is organized and funded by a company in England called Autifony Therapeutics Limited (www.autifonytherapeutics.com), and they have designated USF as the Lead Clinical Trial site for this FDA Phase 2 Trial.
The primary goal of this proposal is to investigate the potential therapeutic roles of modulating the action of voltage-gated potassium channels in the brain for mitigating key elements of presbycusis, such as improved speech-in-noise recognition and processing. The new drug is given each morning orally.
Defining these neural ion channels as a therapeutic target comes from several provocative lines of research:
- These channels are involved in how the brain codes timing features of sound perception
- The ability to discriminate timing features of sounds is a key component for proper speech and music perception
- The ability of the brain to encode sound timing features and speech declines with age
- There is some direct evidence from animal model studies that these potassium channels are one of the biological mechanisms underlying ARHL. For example:
Reference: Zettel, M.L., Zhu, X., O’Neill, W.E., Frisina, R.D. (2007) Age-related Declines in Kv 3.1b Expression in the Mouse Auditory Brainstem Correlate with Functional Deficits in the Medial Olivocochlear Efferent System. J. Assoc. Res. Otolaryngology – JARO, 8:280-293.
For more information:
CSD Lab #: 813-974-1262
CSD Lab Email: firstname.lastname@example.org