Testing the Safety and Effectiveness of Clemastine Fumarate with Engineered Sound to Treat Age-Related Central Auditory Processing Disorder in Adults Aged 45 to 65

What this Trial Is About

Researchers are investigating the use of Clemastine Fumarate combined with engineered sound to treat age-related central auditory processing disorder CAPD, a condition affecting many people over 40 and causing difficulty hearing in noisy environments. This trial aims to test if the therapy, called Localized Oligodendrocyte Optimization Therapy LOOT, which showed promise in animal studies, can improve hearing in noise for humans. The study is designed to compare the effectiveness of the drug with or without engineered sound in a controlled, randomized setting. Participants will be randomly assigned to one of four groups Clemastine Fumarate with engineered sound, Clemastine Fumarate with placebo sound white or pink noise, placebo drug with engineered sound, or placebo drug with placebo sound. The drug dosage is carefully controlled and given orally over 30 days, while participants listen to the assigned sound stimulation through headphones for one hour daily. The trial includes an adaptive design allowing adjustment of study arms based on interim results. Throughout the study, participants will undergo hearing tests to measure their ability to hear in noisy environments, both before and after treatment. Additional assessments include questionnaires on speech and tinnitus, auditory brainstem response tests, physical exams, blood tests, and EKGs to monitor health and safety. The treatment period lasts one month, with evaluations scheduled around weeks five or six. Safety and hearing improvements are carefully monitored to assess the therapys impact.

A Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound