Clinical Research Directory

Prevention of Noise-Induced Hearing Loss in Primary Education

The goal of this randomized controlled trial is to evaluate the effectiveness of the educational program the HoorToren in promoting recreational safe listening behavior among Dutch primary school children in group 7 (aged 10-11 years) and thereby contribute to preventing noise-induced hearing loss. The main objectives are: * To evaluate the HoorToren's effects on promoting the child's safe listening behavior when using headphones or earbuds. Both safe listening and its psychological determinants will be measured. * To evaluate the HoorToren's effects on parents' perception of their child's safe listening behaviors. The effects on parental behavior promoting or facilitating their child's safe listening behavior, including its psychological determinants, will also be evaluated. Researchers will compare children who receive lessons from the HoorToren educational program, and their parents (intervention group) with children and their parents who do not receive the lessons (control group) to evaluate the effectiveness of the HoorToren. Outcomes will be assessed using newly developed and validated self-report questionnaires for both children and their parents. Additionally, the child's listening behavior will be measured via a smartphone application installed on the child's phone. Measurements will take place at four time points during the school year.

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

The goal of this clinical trial is to determine the efficacy of Clemastine Fumarate in the presence of engineered sound to treat age-related central auditory processing disorder (CAPD). This disorder impacts 800M patients worldwide, including \~1/3 people over 40 years of age and \~1/2 people over 65, resulting in an inability to hear in noisy environments. The primary hypothesis this study aims to test is: engineered sound, driving localized neural circuit activity, will enable Clemastine Fumarate to mature Oligodendrocyte cells and thus remyelinate these activated neural circuits. This Localized Oligodendrocyte Optimization Therapy (LOOT) was highly effective in preclinical animal studies so this clinical trial aims to answer if this therapy will translate to humans. The study is an adaptive design intended to compare the efficacy of the drug in the presence or absence of the engineered sound for improving hearing in noise ability. Trial participants will be tested for hearing thresholds and ability to isolate a sound signal from background noise. If they meet the inclusion criteria, they will be enrolled into one of the four arms of the study and undergo the proposed one-month treatment (drug and sound or respective placebos). After the treatment period, trial participants will be tested again for hearing thresholds and their ability to isolate s sound source of interest from background noise. The hypothesis to be tested in this clinical trial is that the one-month treatment will significantly improve the participant's ability to isolate a sound source of interest from background noise. The design has four arms, drug+sound, placebo+sound, drug+white noise, and placebo+white noise. Based on our preclinical data, control arms are all expected to show identical results, thus our adaptive design includes interim analyses to allow for dropping of two of the three placebo arms should the preclinical results be replicated as anticipated. We will also monitor each participant's general health during the duration of the clinical trial, which will be done by performing a number of blood tests, an EKG and a general physical before and after the one-month treatment period. We expect no significant changes since participants will take the drug for the one-month period at dosages already demonstrated safe in several Phase II studies of multiple sclerosis. Similarly, the engineered sound will be listened to for one hour per day during this month at sound intensities well below threshold that might cause noise-induced hearing damage.