Clinical Research Directory

Apple Hearing Study

The Apple Hearing Study is a partnership between the University of Michigan and Apple to study sound exposure and its impact on hearing health. This groundbreaking study will advance the understanding of how hearing could be impacted over time by exposure to sound at certain levels. The investigators will measure headphone and environmental sound exposures over time among participants, and determine how these exposures impact hearing and stress levels. US residents who own an iPhone, download the Apple Research app and consent to participate will be randomly assigned to two groups, one with a "Basic" user interface in the Research app, and one with an "Advanced" user interface. Users in the "Advanced" group will receive additional information about their exposures and be given additional surveys and hearing tests based on their music and environmental sound exposures. The study will provide investigators with a better understanding of listening behavior and its overall impact on hearing health. This information will in turn help guide public health policy and prevention programs designed to protect and promote hearing health in the US and globally.

ENACT Program on Auditory Perception and Function, Cognitive Function and Health-related Quality of Life

Although previous studies indicated that tackling hearing loss may have a secondary benefit in improving cognitive function and delaying the onset of dementia, a more integrated care approach to optimize both hearing and cognitive function may be needed for individuals who already developed cognitive decline. To address the dual care needs for PwMCI and hearing impairment, it may be possible to integrate auditory training into cognitive training, as both of them are activity-based and focus on increasing the attention and working memory of an individual to engage in the auditory communication process. Moreover, auditory instruction is one of the core mediums in delivering cognitive training activities. It is highly possible to integrate the auditory training curricular to the corresponding administration process. To tackle the enhanced support need of individuals with dual functional impairment to engage in an integrated training protocol, strategies including a goal-oriented approach and peer support can be integrated to optimize the empowerment network. Including family members in the training is also important, as the auditory-communication process in everyday life would take place in the social interactional context. This is a pilot mixed-method pilot study comprising a randomized controlled trial and a post-trail qualitative interview. A total of 62 participants will be recruited from two community centers. The inclusion criteria include mild cognitive impairment according to Petersen's criteria; with at least one-side hearing impairment as defined by a score of 2- or 3-digit test greater than the norm value on the integrated Digit-in-Noise (iDIN test); has a smartphone to access the online training materials; not received formal cognitive and auditory training in the past 6 months. After the baseline outcome evaluation, they will be randomized to receive the 12-week ENACT program or the usual care control. The nurse-led ENACT program comprises three phases, including i) the goal-oriented health counselling phase, ii) the peer-assisted group-based auditory-cognitive training phase, and iii) the family-engaged active-communication training phase. The outcome evaluation on hearing function, perceived benefit of auditory training, cognitive function, and HRQoL will be assessed at baseline, in the 12th and 18th weeks. Qualitative interviews will be conducted

New Hearing Aid Users and Their Social Participation

Does first-ever hearing aid fitting change social participation? Using a mixed methods approach made up of audiological assessments (hearing test and examination of the ear canal and eardrum), questionnaires, semi-structured interview and surveys, the study aims to gain a comprehensive and in-depth understanding of the experiences (in the first 12-13 months) of initial hearing aid users in relation to their social participation. PRIMARY OBJECTIVE The primary outcome measures will be to compare scores on the ecological momentary assessment (EMA) ratings of social engagement and experience for social participation situations over the course of a participant's 13-month involvement in the study. Differences in an individual's social networks analysis (SNA) will be examined in this longitudinal study to see if there are changes in social structure over time. This will involve looking at the network size, number of connections related to activities someone does, how they feel about the social connections and the support they get from their social network. Assessing longitudinal changes in: * International Outcome Inventory for Hearing Aids (IOI-HA) questionnaire - effectiveness of hearing aid(s). * Revised Hearing Handicap Inventory (RHHI) - emotional and social impacts of hearing loss. * Social Participation Restrictions Questionnaire (SPaRQ) - how hearing limits social life * The Hearing-Related Lifestyle Questionnaire (HEARLI-Q) - the influence of hearing ability in everyday listening situations. Qualitative outcome measures - investigating the semi-structured interview and open text box response answers over the longitudinal study to explore personal perspectives, motivations and responses to questions related to social participation difficulties and avoidance, using reflexive thematic analysis

Automated Text Message Reminders to Promote Hearing Aid Adoption

Many individuals with hearing loss do not receive adequate hearing healthcare. Only about 30 percent of people that are found to have hearing loss during a hearing test go on to use hearing aids. The investigators propose to test the use of text message reminders to educate patients with hearing loss, and to encourage them to get hearing aids. The study objective is to examine whether automated text-messaging reminders increase the use of hearing aids among patients with hearing loss, who are hearing aid candidates.

Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.

Background: People with hearing, balance, and taste, smell, voice, speech, language, and other Ear, Nose, and Throat (ENT) disorders may seek treatment at the National Institute on Deafness and Other Communication Disorders (NIDCD). Some of these people may benefit from enrolling in the NIDCD intramural research program to receive their care. Enrolling will also allow investigators to collect participants clinical data and specimens for future research. Objective: This natural history study has 2 goals: (1) to collect data and specimens that may be used for research; and (2) to evaluate participants who may be candidates for other research studies. Eligibility: People aged 2 years or older with a hearing, balance, and communication disorder. Those at risk or who are suspected of having such a disorder are also eligible. Design: Participants will be screened. Their medical records will be reviewed. Participants will agree to have their medical data used for research. Specimens such as blood or other tissue samples may also be used for research. All data and specimens will be collected during their routine care visits. All tests done will be the normal care for each participant s condition. No tests will be done solely for research. Some of these tests may require blood or tissue samples. Some may use special tools to test hearing and balance. Some may test heart or lung function. These tests may also include different types of imaging scans. All tests will be explained. Participants may ask questions at any time. Participants may remain in this study for up to 2 years. If they need further care, they may sign a new consent. ...

Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device

The purpose of this study is to develop and validate methods to use hearing aids equipped with embedded sensors and artificial intelligence to assist in the assessment of fall risk and in the implementation of interventions aimed at reducing the risk of falling, as well as to improve speech intelligibility in quiet and in background noise, track physical activity, and social engagement. The investigators hope is that the knowledge that is generated through this study will ultimately translate to the clinical setting and will help reduce the likelihood that individuals experience a fall, and improve the quality of hearing in individuals who wear hearing aids.

Natural History of Autosomal Dominant Hearing Loss

Background: Hereditary hearing loss is one of the most common sensory disabilities affecting newborns. The main options for people with hereditary hearing loss are hearing aids and cochlear implants. Both options have their limitations and do not restore biological hearing. Researchers want to learn if gene editing might be a treatment option. Objective: To understand the genes that cause non-syndromic autosomal dominant hearing loss (DFNA) in people with DFNA as well as their family members. Eligibility: People age 3 99 who have DFNA, affected family members of enrolled participants with DFNA, and unaffected family members of enrolled participants Design: Participants will be screened with a medical and hearing history. Their medical records will be reviewed. Participants will have hearing tests. They will wear headphones or earplugs. They will listen to tones, sounds, and words and may be asked to describe what they hear. Participants will have balance tests. For these, they will wear googles as they watch moving lights or as cold or warm air is blown into their ears. They will sit in a spinning chair in a quiet, dark booth. From a reclined position, they will raise their head while listening to clicking sounds. Participants will have blood drawn through a needle in the arm. Some blood will be used for gene testing. Some participants will have 2 skin biopsies. The skin will be washed, and a numbing medicine will be injected. Two small pieces of skin will be removed. Participants may have a physical exam. Participation will last for up to 20 years. Participants may give medical updates once a year.

Self-monitoring of Hearing Aids Using Artificial Intelligence

This project investigates how self-monitoring of hearing aids through an AI-based mobile app can complement physical and digital healthcare visits. The aim is to increase patient involvement in rehabilitation, enable hearing aid adjustments in everyday sound environments, and improve access to hearing care.

A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults

The aim of this clinical investigation is to demonstrate the performance, clinical benefit and safety of commercial cochlear implant systems. Speech performance and subjective hearing results, and comparison with cochlear implant results available in literature, is intended to demonstrate the performance and clinical benefit of the cochlear implant systems investigated in this study.

An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App

The study is a feasibility, prospective, repeated-measures, multi-country, multi-centre, study of the Mobile Research App to measure and validate speech perception endpoints in adult cochlear implant recipients.

Nucleus Hybrid L24 Extended Duration Post Approval Study

This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid L24 Implant System in a group of already implanted recipients.

Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer

The goal of this observational study is to learn about the occurrence of and to identify suitable strategies for screening and monitoring of inner ear damage in patients receiving cisplatin chemoradiotherapy for head and neck cancer. Researchers will compare patients who are receiving cisplatin chemoradiotherapy to patients who are only receiving radiotherapy. Patients will undergo standardized testing for hearing loss, tinnitus and vestibular dysfunction at baseline, during and after treatment. Optional genetic analyses will aim to identify genes known to predispose to cisplatin-induced ototoxicity.

Clinical Utility of Residual Hearing in the Cochlear Implant Ear

The current study is a randomized multi-center clinical trial that investigates the role an intraoperative hearing monitoring system (electrocochleography) has on helping to save residual hearing in patients undergoing cochlear implantation (CI).

Hearing Outcomes With the Nucleus® 8 Sound Processor and Nucleus® 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients

The main purpose of this study is to understand how well a noise reduction feature called ForwardFocus works when used with two different sound processors: the Nucleus® 8 Sound Processor and the Nucleus® 7 Sound Processor, in adults with cochlear implants. The study will include two groups of adult cochlear implant recipients: veterans and non-veterans. Comparing these groups will help researchers understand how these sound processors perform in veteran populations as well as the broader adult cochlear implant community. Participants will use each sound processor and then take part in speech understanding tests in background noise. They will also complete questionnaires about their listening experiences with each processor.

Auditory-Cognitive Optimization Care Program for Older Adults With Hearing Loss and Cognitive Impairment

Hearing loss and cognitive impairment are common and interrelated health problems that may affect communication, information processing, attention, psychological well-being, daily functioning, and quality of life. This study aims to develop and evaluate a comorbidity-oriented Auditory-Cognitive Optimization Care Program (A-COP) for individuals with hearing loss and cognitive impairment. The A-COP will be developed based on evidence from a literature review and findings from qualitative research involving individuals with hearing loss and cognitive impairment and their caregivers. The program integrates hearing-related care and cognitive stimulation strategies to address the combined needs associated with hearing and cognitive difficulties. In the intervention phase, participants will be randomly assigned to either the A-COP intervention group or an active control group in a two-arm, parallel-group randomized controlled trial. The study will evaluate changes in cognitive function, hearing and communication-related outcomes, depressive symptoms, and quality of life from baseline through the 6-month follow-up. The findings will provide evidence regarding the effects of the A-COP in individuals with hearing loss and cognitive impairment.

Hearing Impairment, Strategies and Outcomes in VA Emergency Departments

HearVA involves six VA facility emergency departments (ED) over a 3-year intervention period. The first part of this study will test whether providing personal amplifiers to Veteran ED patients who self-report hearing difficulty is acceptable to these patients, can improve their hearing, enhance understanding of discharge instructions, and can reduce the risk of coming back to the ED in a short period of time (3 days and 30 days). The second part of the study will then identify whether ED staff can implement this program and achieve similar results. The second part will give ED staff increasing levels of responsibility for screening Veterans for hearing difficulty and providing personal amplifiers when such difficulty is detected.

NIDCD Otolaryngology Clinical Protocol Biospecimen Bank

Background: Many disorders of the head and neck can affect a person s hearing; balance; smell; taste; swallowing; voice; or speech. These disorders include cancers and genetic and inflammatory diseases. To find better ways to diagnose and treat these disorders, researchers need to study tissues and other biological samples from people who have them. Objective: To collect biological samples for a repository that will be used for research. Eligibility: People of any age with a disorder of the head and neck that requires the taking of biological samples. The conditions may be any that affect hearing; balance; smell; taste; swallowing; voice; or speech. Design: Part 1: Participants will give permission for their leftover tissue samples to be used for research. These are tissue samples from the head and neck that were collected in the course of routine tests and care or other research studies. Information on each participant s age, diagnosis, and previous treatments will also be collected. Part 2: Some participants may be asked for more samples. All those aged 3 years or older will have a physical exam. They will provide blood and saliva samples. A cotton swab or brush will be used to collect cells from the inside of the cheek. Participants 18 years or older may have additional tests. They may provide nasal secretions: A piece of gelfoam or a sponge will be placed in the nose to soak up secretions for 5 to 10 minutes. They may have biopsies: Small samples of tissue will be cut from the skin and the tissue lining the mouth. Samples may be used for genetic testing.

Improving Spatial Perception and Speech Understanding in Multitalker Mixtures

The purpose of this study is to investigate several approaches for improving spatial perception and speech intelligibility in multitalker listening situations for hearing-aid users. The hypotheses are that spatial perception and speech intelligibility will be improved by (1) increased high-frequency audibility, (2) speech envelope enhancement, and/or (3) appropriate sound image externalization.

The Hear Clear Study

The purpose of this study is to determine if hearing aid use helps adults with "normal" hearing on clinical hearing tests (i.e., pure-tone audiogram), but who report hearing trouble in everyday life. Another purpose is to understand what factors and hearing aid features provide the most help for these people.

Optimization of Hearing Performance in the Subject Implanted

In the past two decades, the selection criteria for cochlear implantation have been greatly relaxed so that about 60-70% of present cochlear implant (CI) candidates have significant residual hearing in their contralateral ear. However, contralateral hearing is often not considered in rehabilitation programs, mainly due to the lack of scientific evidence on the role it may play. The present project aims to better understand the mechanisms of perceptual learning of CI-processed speech after implantation and to develop and test rehabilitation strategies for CI users.

OTC Hearing Aid and MCI

The goal of this study is to better understand if, in patients with mild to moderate hearing loss who are also experiencing mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD), Over-the-Counter (OTC) hearing aids: 1. improve communication 2. Whether the magnitude of benefit depends on the patient's level of cognitive disability, 3. Whether alternative remediation (such as targeted communication strategies) offer similar benefits. Participants and a communication partner will be randomized into an OTC first or Communication Strategies first arm, where participants will receive communication strategy information customized for those with cognitive impairment.

Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer

Background: Cisplatin is used to treat head and neck cancer. People who take this drug are at risk for hearing loss. Atorvastatin is a drug used to treat high cholesterol. It might reduce the risk of cisplatin-induced hearing loss. Objective: To find out if atorvastatin reduces hearing loss in people treated with cisplatin and radiation. Eligibility: People ages 18 and older with squamous cell carcinoma of the head and neck who will undergo treatment with cisplatin-based chemotherapy and radiation Design: Participants will be screened with their medical records. Participants currently taking a cholesterol-lowering statin medication are invited to participate in the observational arm of the study. Those not taking such a medication are invited to participate in the interventional arm of the study. All participants will have 3 study visits for the purpose of evaluating hearing. One before starting cisplatin treatment, one within 3 months of completing cancer treatment, and one within 2 years of completing cancer treatment. They will have tympanograms. A small flexible tip will be placed in the ear canal. A puff of air will be delivered to assess mobility of the ear drum. They will have hearing tests. They will wear headphones. They will listen to tones that vary in loudness. They will be asked to indicate when they hear a sound. They will complete 3 questionnaires at the time of each hearing test. Participants will have 2 visits for blood tests. These will occur upon consent and 12 weeks after. They will be randomly assigned to take the study drug or placebo orally, once daily. They will take it during cisplatin treatment and for 3 months after treatment. Long-term follow up will include a chart review 2 years after participants complete their cisplatin therapy.

Auditory Restoration and Outcomes After Gene Therapy and Cochlear Implantation: a PRospective Cohort Analysis (AURORA)

This cohort study aims to explore the trends and differences in multidimensional perceptual levels of patients after cochlear implants or gene therapy, as well as to comprehensively assess the efficacy of gene therapy for congenital deafness, thus providing a reference for making a well-rounded postoperative rehabilitation protocol for gene therapy patients.

Listening Effort in Cochlear Implant Users

People with hearing loss experience extra effort when listening, which can lead to severe psychological barriers to communication and social participation. Listening effort can lead to fatigue, mental strain, burnout, medical sick leave, and the need for increased time to recover from regular daily activities. This proposal aims to understand effort changes on a moment-to-moment basis during listening, how long the effort lasts, and how the planning and execution of effort is impacted by the experience of using a cochlear implant.