Clinical Research Directory

HEARS Maryland: Extending Capacity for Affordable, Accessible Hearing Care Through Older Adult Peer Mentorship

This study aims to assess the effectiveness of a Community Health Worker (CHW) delivered hearing loss intervention program (HEARS) for older adults in Maryland in collaboration with community organizations.

WhatsApp AI Support vs Paper Support for First-Time Hearing Aid Users

The purpose of this study is to advance hearing care in low- and middle-income countries (LMICs) through the rigorous evaluation and optimization of innovative interventions and technologies. This study encompasses the following key aim: This study aims to evaluate the effectiveness of a WhatsApp-delivered AI-enabled support and acclimatization programme for adults receiving preset hearing aids in low-resource community settings. The AI-enabled programme combines two complementary components delivered through the same WhatsApp channel: (i) a structured push programme of 16 voice notes and images delivered over four weeks, and (ii) an on-demand artificial-intelligence (AI) conversational support agent available throughout the four-week intervention period. The primary objective is to determine whether this WhatsApp-delivered AI-enabled programme results in superior hearing aid self-efficacy compared to receiving the equivalent core information in a paper-based pamphlet at the time of fitting. By comparing hearing aid self-efficacy, hearing aid outcomes, and user engagement between the intervention (WhatsApp AI-enabled) and control (paper-based) groups, this study seeks to establish whether AI-enabled digital delivery provides superior support and leads to better self-efficacy for first-time hearing aid users compared to traditional paper-based methods.

Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)

This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to investigate the complication rate for procedures performed out-of-OR.

Same-Day Cochlear Implant Activation (SDA-CI)

This randomized controlled study investigates whether activating a cochlear implant on the day of surgery (same-day activation) leads to faster stabilization of cochlear implant programming compared with the current standard practice of activation approximately 14 days after surgery. Adult cochlear implant recipients at Aarhus University Hospital will be randomly assigned to either same-day activation or standard activation. The study will evaluate electrode impedance development, time to a stable cochlear implant map, changes in programming parameters, hearing outcomes, tinnitus, quality of life, rehabilitation progress, and safety. The purpose of the study is to determine whether earlier activation can facilitate faster auditory rehabilitation and optimization of cochlear implant settings without increasing complications or patient discomfort.

Cochlear Implants in Young Children With SSD

The goal of this clinical trial is to investigate the safety and effectiveness of cochlear implantation in infants and toddlers with single-sided deafness. The main questions it aims to answer are: * Are cochlear implants an effective treatment of single-sided deafness in infants and toddlers? * Are cochlear implants a safe treatment for single-sided deafness in infants and toddlers? Participants will receive a cochlear implant and be followed until they are five years old. During those five years, the investigators will program the device and monitor auditory development. Children will be asked to: * Undergo cochlear implantation * Wear their cochlear implant processor whenever they are awake. * Participate in traditional hearing tests * Participate in traditional hearing testing * Participate in localization testing * Participate in hearing in noise testing * Participate in word recognition testing * Participate in speech, language, and educational evaluations The researchers will compare results to children with typical hearing in both ears and children with single-sided deafness who have not received an implant to observe any differences between the groups.

SPI-1005 in Adults Receiving Cochlear Implant

The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear. The main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and/or what medical problems might participants experience when taking drug SPI-1005? The clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant. Participants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests. The effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have.

ACHIEVE Hearing Intervention Follow-Up Study

The ACHIEVE Hearing Intervention Follow-Up study is a randomized trial of a telehealth versus conventional clinic-based hearing healthcare (HHC) delivery model among older adults who are existing hearing aid users to determine if a telehealth HHC model improves hearing aid use and other communication outcomes compared to clinic-based HHC.

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.

SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss

Chemotherapy treatment with platinum based agents is well noted to cause ototoxicity. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy in head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.

Perception of Speech in Context by Listeners With Healthy and Impaired Hearing

Recognition of speech sounds is accomplished through the use of adjacent sounds in time, in what is termed acoustic context. The frequency and temporal properties of these contextual sounds play a large role in recognition of human speech. Historically, most research on both speech perception and sound perception in general examine sounds out-of-context, or presented individually. Further, these studies have been conducted independently of each other with little connection across labs, across sounds, etc. These approaches slow the progress in understanding how listeners with hearing difficulties use context to recognize speech and how their hearing aids and/or cochlear implants might be modified to improve their perception. This research has three main goals. First, the investigators predict that performance in speech sound recognition experiments will be related when testing the same speech frequencies or the same moments in time, but that performance will not be related in further comparisons across speech frequencies or at different moments in time. Second, the investigators predict that adding background noise will make this contextual speech perception more difficult, and that these difficulties will be more severe for listeners with hearing loss. Third, the investigators predict that cochlear implant users will also use surrounding sounds in their speech recognition, but with key differences than healthy-hearing listeners owing to the sound processing done by their implants. In tandem with these goals, the investigators will use computer models to simulate how neurons respond to speech sounds individually and when surrounded by other sounds.

ACHIEVE Brain Health Follow-Up Study

The ACHIEVE Brain Health Follow-Up Study is a 3-year follow-up to the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized study to determine the long-term effect of hearing intervention vs. successful aging/delayed hearing intervention on rates of cognitive decline and incident mild cognitive impairment or dementia.

Investigating the DNN Noise Reduction Feature in Phonak Hearing Aids Using Ecological Momentary Assessment

The goal of this interventional study is to evaluate the DNN Noise reduction feature of Phonak hearing aids in adults with moderate to moderate severe hearing loss. The main questions it aims to answer are: Do participants correctly identify significantly more words on the AZBio Sentence Test when using Phonak's DNN NR feature than when using Competitor device A in a lab setting? Do participants subjectively rate the speech clarity, ease of listening, and listening confidence higher when using Phonak's DNN feature than when using Competitor device A in both a lab setting and a real-world cafe setting? Do participants have an overall preference for the Phonak device over the Competitor device A in a real-world cafe setting? Participants will be fit with both the Phonak device and a Competitor device A in the lab. They will be given the AZBio Sentence test and repeat as many words as they can in a simulated noisy environment. Following the lab visit, participants will meet in a group with three other conversation partners in a real-world setting and asked to complete subjective questionnaires during the visit.

Remote Microphone Performance Comparison in Adults With Hearing Loss

This study will compare far-field speech understanding in noise using a hearing aid alone, with using a hearing aid plus a Roger remote microphone. It will also compare the HA+Roger mic to two other manufacturers' hearing aids plus remote mic systems in the same condition.

New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.

The purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for CI listeners. The Clinical Investigation will be comprised of several arms which will aim to optimize speech enhancement algorithms, to improve real-world functionality, and to incorporate them efficiently into CI speech processors.

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.

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.

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.

School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Kentucky

This trial will evaluate a multilevel intervention (STAR model) that combines mobile health (mHealth) hearing screening tools with telemedicine technology for specialty care access in rural Kentucky schools. An initial version of the model was used in rural Alaska where telemedicine-based specialty referral improved both proportion of children receiving follow-up and time to follow-up. The refined STAR model will utilize an enhanced mHealth screening protocol that includes tympanometry for the detection of middle ear disease. The STAR model will also include a specialty telemedicine referral process in schools for children who refer school screening.

School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Alaska

The prevalence of childhood hearing loss in rural Alaska is disproportionately high and predominately infection-related. With preventive screenings and access to health care, much of childhood hearing loss is preventable. Although state-mandated school screening helps identify children with hearing loss, loss to follow-up is pervasive and exacerbated by a scarcity of specialists in rural regions. A mixed methods cluster randomized trial conducted in northwest Alaska demonstrated that telemedicine can significantly reduce loss to follow-up. This stepped wedge trial, in partnership with Southcentral Foundation, will build on this existing work to develop a model that can be scaled in diverse environments. We will adapt and implement a new telemedicine intervention called Specialty Telemedicine Access for Referrals (STAR). This trial will be conducted in 3 regions in rural Alaska that represent multiple healthcare systems. Based on stakeholder feedback and evidence generated from the previous trial, an enhanced mobile health (mHealth) hearing screening will be implemented in all participating schools prior to the STAR intervention, and the telemedicine referral to specialty care (STAR intervention) will be moved from the clinic directly into the school. This stepped-wedge cluster randomized trial is part of a larger hybrid type 1 effectiveness-implementation trial. The stepped wedge trial will evaluate the effectiveness of the STAR intervention in reducing loss to follow-up from referred school hearing screening in 3 regions of Alaska: Kodiak, Petersburg and Lower Yukon (n=23 schools, \~2,015 K-12 students/year). The STAR Intervention will be compared to the standard referral of a letter home to families. Cluster randomization at the level of school will be performed, with schools (clusters) randomized to one of two sequences. The effectiveness outcome (i.e., proportion of children who receive follow-up) will be evaluated over three academic years (2023-2026), with STAR rolled out in a stepwise manner for each of the two sequences (academic year 2024-2025 for sequence 1 and academic year 2025-2026 for sequence 2). The control periods for each sequence will be academic year 2023-2024 for sequence 1 and academic years 2023-2024 and 2024-2025 for sequence 2. Enhanced screening will be rolled out to both sequences at the same time (i.e., non-randomized) beginning academic year 2023-2024. An implementation evaluation will be conducted to refine and adapt the enhanced hearing screening and STAR intervention throughout the trial. Implementation data will be collected starting academic year 2022-2023 and then annually for each of the subsequent years. Timeline update: Based on feedback from community partners, we extended the trial for one year to allow for community-informed adaptations of the enhanced screening. Now the STAR intervention will be rolled out in 2025-2026 for sequence 1 and 2026-2027 for sequence 2.

Opto-electrical Cochlear Implants

Neural stimulation with photons has been proposed for a next generation of cochlear implants (CIs). The potential benefit of photonic over electrical stimulation is its spatially selective activation of small populations of spiral ganglion neurons (SGNs). Stimulating smaller neuron populations along the cochlea provides a larger number of independent channels to encode acoustic information. Hearing could therefore be restored at a higher fidelity and performance in noisy listening environments as well as music appreciation are likely to improve . While it has been demonstrated that optical radiation evokes auditory responses in animal models, it is not clear whether the radiant exposures used in the animal experiments are sufficient to stimulate the auditory system of humans. The proposed tests are: 1. to demonstrate that light delivery systems (LDSs) can be inserted and oriented optimally in the human cochlea. 2. to show that the LDSs are able to deliver sufficient amount of energy to evoke a compound action potential of the auditory nerve. 3. to validate that the fluence rate (energy / target area) required for stimulation is below the maximal fluence rate, which damaged the cochlea in animal experiments. 4. to show that combined optical and electrical stimulation is able to significantly lower the threshold required for optical stimulation in humans. The endpoints for the study are either the completion of the experiments proposed or the demonstration that not sufficient energy can be delivered safely in the human cochlea to develop an action potential.

Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation

This study will evaluate hearing outcomes after cochlear implantation with placement of the ECE1 ground electrode near the post-auricular vagus nerve (Arnold's nerve) to assess non-inferiority with respect to placement under the temporalis muscle.

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.

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.

Evaluation of the Impact of Cochlear Implants on Cognition in Older Adults

The subjects will be age 65 years and older, with no upper limit of age range with hearing loss that are candidates for standard-of-care cochlear implant. Cognitive tests will be administered preoperative, and postoperative at 6 and 12 month, and 5 year intervals.