This study wants to see if an FDA-approved drug called Clemastine Fumarate and sound therapy can help improve hearing problems in noisy places that some people get as they age called age-related auditory processing disorder.
Currently, there is no treatment for this type of hearing loss that some people get as they age. This study wants to learn if drug treatment and sound therapy work for this condition. If you join this study, you will first have a screening visit to see if you are a good fit. At this visit, you talk about the research and go over a brief medical history. If you can join the study, you will then have 1-2 visits, called baseline visits, in person. At these visits, you will have a physical exam, blood draw, EKG, and the study team will review your health history. If needed, you may be asked to take a pregnancy test. You will then have a hearing test in a sound booth, sound localization testing, brain wave recordings, and answer questions about your hearing. You may take home an MP3 player, headphones, and medication from this visit, or they will be mailed to you. You will be put into one of four treatment groups, either drug and sound, placebo (a drug with no medication) and sound, drug and white noise, or placebo and white noise. You will not know which group you are in, and neither will the study team. After the baseline visits, you will begin the treatment period which will last for one month. You will take your drug daily and listen to a sound through headphones for 1 hour. You will keep a daily diary of your activities. You will also answer a phone call from the study team. After you finish the treatment phase, you may be able to take part in 1-2 more optional post treatment visits in person. At these visits, you will have all the baseline hearing tests and surveys and review any side effects from the study drug. You will be paid a total of $250 for taking part in the study. If you leave the study early, you will be paid for visits you complete.
You may be able to join this study if you are a male or female between 45 and 65 years old and have difficulty understanding speech in noisy environments and have no more than mild high frequency hearing sensitivity loss and normal middle ear function.
Protocol Number: 25-1184
More information available at ClinicalTrials.gov: NCT07304024
Principal Investigator