Clinical Research Directory

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.

Knowledge and Beliefs of Hearing Impaired Individuals Regarding Human Papillomavirus (HPV)

Health education is one approach to influencing individuals, groups, or communities to achieve better health. The literature indicates that increasing awareness of HPV, along with participation in early screening and vaccination programs, can positively influence attitudes and behaviors. Therefore, this research will be conducted to determine the effect of education using the card game method on the knowledge and health beliefs of hearing-impaired individuals regarding Human Papilloma Virus (HPV).

Effects of an Online Hearing Support for First-time Hearing Aid Users

The goal of this randomised controlled trial is to test a online hearing support for first-time hearing aid users. The main questions it aims to answer are short- and long-term effects on the emotional and social consequences of hearing loss that the participants experience, use of communications strategies, experienced listening in complex sound environments and perceived effectiveness and satisfaction with hearing aids.

Training Listening Skills With the Inclusion of Cognitive Control

Participating in spoken conversation constitutes a multitasking situation with concurrent demands on sensorimotor (auditory, postural) and cognitive functioning (memory, updating, task switching and inhibition). As aging affects multisensory integration and cognitive control, these higher-order processes are likely to put accumulating constraints on listening as adults grow older. By training listening skills (not solely auditory skills), the investigators aim at improving overall communication and quality of life. Moreover, the investigators aim at freeing up cognitive resources in the listen task: the better one gets at a certain domain specific task, the less one needs to draw from other resources and, the more resources are free for another concurrent task. The interdisciplinary approach will inform us about ideal audiological rehabilitation or intervention approaches. Pre-posttests comprise behavioral measures to evaluate listening skills and transfer towards non-trained measures. The training is tablet-based and can be performed at home.

Motivational Interviewing in Hearing Aid Users

Hearing loss is one of the most common chronic disabilities in the older adult population and affects their quality of life. Hearing aid use can improve one's quality of life by increasing a person's ability to detect, differentiate and locate sound, and improve speech recognition. Several factors seem to reduce motivation to use a hearing aid. Fears of exclusion and shame due to hearing loss are major deterrents to hearing aid use. Motivational interviewing (MI) is a counselling style aimed at creating desire in patients to change their behavior. There have been pilot studies that suggest one-on-one MI can increase hearing aid use, but other pilot studies found the reverse hence the evidence is inconclusive. The effectiveness of group MI therapy is also being investigated in MI research. While results in group MI research are promising, studies investigating group MI have been limited to substance abuse.