Clinical Research Directory

Preventing Noise Exposure in Farmworkers

This study will evaluate a farmworker-level hearing loss prevention training designed to improve hearing protection use among farmworkers exposed to hazardous occupational noise. The intervention consists of a culturally and linguistically adapted, Spanish-language digital training module paired with hands-on earplug fitting and coaching. The primary goals of the study are to (1) assess the feasibility and acceptability of delivering the adapted training in community-based settings, and (2) estimate preliminary effectiveness using an objective measure of hearing protection fit. The study uses a single-arm, pre-post pilot design. A small group of farmworkers will complete pre- and post-training assessments of earplug fit, as well as brief surveys assessing hearing protection knowledge, attitudes, and perceptions. Qualitative feedback will be collected to inform refinement of the training and guide future scale-up. Results will inform the development of a subsequent multilevel intervention that integrates supervisor and organizational components.

Effect of Operating Room Noise on BIS and Hemodynamics Under General Anesthesia

This prospective observational study aims to evaluate the impact of operating room noise on bispectral index (BIS) and hemodynamic parameters in patients undergoing general anesthesia. Environmental noise in operating rooms, often overlooked, may influence anesthesia depth, patient safety, and physiological stability. A total of 70 adult patients (ASA I-II, 18-65 years, elective surgery under general anesthesia) will be enrolled at Başakşehir Çam and Sakura City Hospital. Patients will be categorized into two groups based on intraoperative average noise levels: noisy group (\>65 dB) and quiet group (\<55 dB). Noise levels will be measured every 10 minutes using a CEM DT-8850 sound level meter, BIS will be recorded every 10 minutes, and hemodynamic variables (systolic, diastolic, mean arterial pressure, and heart rate) will be recorded every 5 minutes. Primary outcome is the correlation between mean intraoperative noise levels (LAeq) and BIS values during the maintenance phase of anesthesia. Secondary outcomes include the relationship between noise characteristics (e.g., device-related, human-related, alarms, media) and hemodynamic stability, as well as surgical branch-related noise classifications (high, moderate, low). The study is non-interventional, with no additional risk to participants beyond standard clinical monitoring. Findings are expected to provide evidence on the role of environmental noise in anesthesia quality, inform operating room organization, and contribute to patient safety improvements.

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.

Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease

Noise from cars, planes, and trains affects all people and has been associated with heart disease. Almost 30% of Americans are exposed to harmful levels of noise and noise accounts for the loss of more than one million healthy life years per year in Europe. Noise causes stress and may be most dangerous when it happens at night. The mechanisms linking noise to heart disease involve changes in the brain and the "fight or flight" response. These changes lead to inflammation and blood vessel disease. However, there are few laws that restrict noise and it is not addressed in medical care. Further, as cities and industries grow, noise continues to increase. Moreover, noise often occurs in areas that are also exposed to other stressors like high air pollution and low income. Yet, there is little research on noise, and it is not known if lowering noise exposure helps heart health. The investigators will use imaging to test if earplugs that block noise improve stress symptoms and changes in the the brain, blood vessels, and stress pathways that lead to disease. The investigators expect that people who use earplugs will have lower measures of stress and heart disease at follow-up. The study will include 26 people with heart disease risk with high noise exposure or who are annoyed by noise. At the first visit, subjects will have imaging of the brain and blood vessels and will have assessments of stress, inflammation, and the "fight or flight" response. They will be assigned to use earplugs or not after the first visit. After 6 months, imaging and other testing will be repeated. It will help to understand how noise impacts the body and whether the effects can be changed. It may also identify important treatments to prevent heart disease in people exposed to noise. By testing if the adverse effects of noise can be lowered with earplugs, this project supports the AHA's mission to be a force for a world of longer and healthier lives.

Comparison of Music and Ambient Noise Cancellation in Patients Undergoing Total Knee Arthroplasty (TKA)

The aim of this clinical trial is to compare the effects of music and ambient noise cancellation during total knee arthroplasty and to analyse the effects on patients. The study will also collect information on patients' functional knee scores and anxiety levels. The main questions to be answered are the following: Does the blocking of music or ambient noise, which is predicted to reduce anxiety, reduce people's anxiety levels? To what extent are participants affected by ambient noise? Does music or ambient noise blocking lead to an improvement in patients' functional scores? The researchers will work with 3 groups of patients who will be exposed to ambient noise blocking, music playing and ambient noise during knee replacement surgery. Participants will do the following: Be asked questions about anxiety and knee function scores before and after surgery. Attend clinical examinations at specified times for checks and tests. Outcomes will be assessed and recorded at appropriate times.

Research on the Sources of Noise in Post Anesthesia Care Unit and the Impact of Noise on Medical Staff

The study aims to clarify the sources and influencing factors of noise in the post anesthesia care unit, as well as the perception of noise by medical staff through survey table, in order to improve the noise environment, optimize noise management, protect medical staff, and enhance medical quality.

Federal Aviation Administration (FAA) National Sleep Study

This observational study will examine the relationship between aircraft noise exposure in the bedroom and objectively assessed sleep disturbance. Surveys will be mailed to randomly selected households around selected airports to recruit individuals for a 5 night in-home sleep study. Eligible survey respondents interested in participating in the sleep study will record nighttime indoor sounds using a portable audio recorder and wear a small device that collects heart rate and movement data for 5 consecutive nights. They will also complete brief morning questionnaires about their previous night's sleep and their sleep quality and a participant characteristics questionnaire. Collected data will be used to create an exposure-response model between aircraft noise exposure and sleep disturbance.

Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss

The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for preservation of sensory structures in the cochlea after noise exposure. The main aims of the study are: 1. To test the safety and best duration for use for a new hypothermia device. 2. To determine if the hypothermia device helps decrease noise-induced hearing loss in a group of firefighters. Participants will wear the mild therapeutic hypothermia therapy devices immediately after a fire service shift serially over a year. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy and a sham therapy).

Hospital Environmental Exposure

There is an increasing body of evidence that human health is affected by environmental factors such as air quality, noise and light. This applies to both indoor and outdoor environments. While there have been several studies looking at homes, offices and work environments, hospital environments are still poorly characterised. Indoor hospital environments are complex, and patients with various health conditions can spend extended periods of time in wards. A number of studies have reported an association of air pollution exposure and a disturbance to sleep. A lack of sleep, or poor and disrupted sleep can impact health. Disturbed sleep therefore can impact a patient's recovery in hospital wards. In addition to the exposure to air pollutants, noise and light levels within the hospital environment can also have an impact on patient health. Inadequate, or a disrupted light and dark cycles can impact the circadian rhythm of the human body, responsible for the sleep cycle. In this study, the investigators aim to characterise these exposures and address the impact of these exposures on the patient sleep. Given the links between sleep and the environmental conditions.

Noise, Oxidative Stress and Cardiovascular System

Environmental noise represents a health problem for at least one in five citizens of the European Union. Noise exposure leads to the development of arterial hypertension, myocardial infarction, stroke, and obesity. Given the limited information on noise exposure and noise effects on humans in the Republic of Serbia, the overall objective of NOXYCARD is to collect environmental noise levels data; to identify long-term and short-term noise effects on the cardiovascular system; and to evaluate the levels of blood stress hormones, oxidative stress, and inflammation in individuals with normal body weight and individuals with obesity.

The Effect of Nonstress Test Device Noise Level on Stress Parameters in Primiparous Pregnant Women

Introduction: Prenatal tests can increase the stress levels of pregnant women. One of the tests performed to evaluate fetal health during pregnancy is the Nonstress Test (NST). Objective: To evaluate the effect of NST device noise level on stress parameters in primiparous pregnant women. Method: A randomized controlled, prospective study was conducted with 44 pregnant women in a State Hospital in Istanbul/Turkey between 01.02.2021 and 01.10.2021. Personal Information Form, Spielberger State Anxiety Inventory, Hillrom Welch Allyn Connex Spot Monitor, Gluco Dr Glucometer, Extech SL 400 Personal Noise Dosimeter, Sennheiser HD 450BT ANC Over-Ear Bluetooth Headset, Eppendorf Tube, Philips Avalon FM20 NST were used to collect data. A p value of \<.05 was considered significant in the statistical evaluation.