ACHIEVE RCT

Aging and Cognitive Health Evaluation in Elders Randomized Control Trial

• NIH/NIA 1 R01 AG055426-01
• The ACHIEVE study will be a randomized controlled trial nested within the Atherosclerosis Risk in Communities (ARIC) study. 850 70-84 year-old cognitively normal older adults with hearing loss will be randomized 1:1 to the hearing intervention (hearing needs assessment, fitting of hearing devices, education/counseling) or successful aging intervention (individual sessions with a health educator covering healthy aging topics). Post baseline, participants will be followed semi-annually for 3 years.
• Enrollment: Concluded. The ARCT lab is a quality control site for this trial.
• USF Principal Investigator:  Theresa Chisolm PhD
• USF Study Team Members: Victoria Sanchez AuD PhD, Michelle Arnold AuD PhD, Haley Neil AuD, Morgan Oktela Fuentes AuD, Marsadi Parliament AuD, Sarah Bochat AuD, Charity Lewis MA
• ClinicalTrials.gov: NCT03243422

ACHIEVE HIFU

Hearing Intervention Follow-Up Study, Randomized Trial of Telehealth vs. Conventional Hearing Care Delivery in the ACHIEVE Study with current hearing aid users

• NIH/NIDCD 1 R01 DC019408-01
• Multi-site randomized trial comparing conventional in-person hearing health care (HHC) versus in-person HHC plus telehealth audiology sessions among existing hearing aid users. Participants will be recruited from the ongoing Aging & Cognitive Health Evaluation in Elders (ACHIEVE) randomized trial in which the investigators recruited 977 adults ages 70-84 with untreated mild-to-moderate hearing loss from January 2018 to October 2019 who were randomized to a hearing intervention (i.e., conventional clinic-based delivery of hearing services and technologies) versus a successful aging education control intervention (i.e., one-on-one sessions with a health educator on topics important for healthy aging). From 2021-2022, as participants in the hearing intervention group (fixed sample, n=490) complete the pre-specified three years of follow-up in the ACHIEVE trial, the investigators will recruit these existing hearing aid users and randomize the participants 1:1 to receive continued conventional clinic-based delivery of hearing care services versus a model that incorporates telehealth. Accounting for loss to follow-up and death, the investigators conservatively estimate that n=400 participants currently in the hearing intervention group will be recruited into this two-year follow-up study.
• Enrollment: Concluded. The ARCT lab is a pilot study site and quality control site for this trial.
• USF Principal investigator: Victoria Sanchez AuD PhD
• USF Study Team Members: Theresa Chisolm PhD , Michelle Arnold AuD PhD, Haley Neil AuD, Morgan Oktela Fuentes AuD, Marsadi Parliament AuD, Charity Lewis MA
• Clinicaltrials.gov: NCT05070429

ACHIEVE SAFU

Successful Aging Group Follow-Up Study, Randomized Trial of Telehealth vs. Conventional Hearing Care Delivery in the ACHIEVE Study with new hearing aid users

• NIH/NIDCD 1 R01 DC019408-01
• Multi-site randomized trial comparing conventional in-person hearing health care (HHC) versus in-person HHC plus telehealth audiology sessions among new hearing aid users. Participants will be recruited from the ongoing Aging & Cognitive Health Evaluation in Elders (ACHIEVE) randomized trial in which the investigators recruited 977 adults ages 70-84 with untreated mild-to-moderate hearing loss from January 2018 to October 2019 who were randomized to a hearing intervention (i.e., conventional clinic-based delivery of hearing services and technologies) versus a successful aging education control intervention (i.e., one-on-one sessions with a health educator on topics important for healthy aging). From 2021-2022, as participants in the successful aging group (fixed sample, n=487) complete the pre-specified three years of follow-up in the ACHIEVE trial, the investigators will recruit these new hearing aid users and randomize the participants 1:1 to receive continued conventional clinic-based delivery of hearing care services versus a model that incorporates telehealth. Accounting for loss to follow-up and death, the investigators conservatively estimate that n=390 participants currently in the hearing intervention group will be recruited into this two-year follow-up study.
• Enrollment: Concluded. The ARCT lab is a pilot study site and quality control site for this trial
• USF Principal investigator: Victoria Sanchez AuD PhD
• USF Study Team Members:  Michelle Arnold AuD PhD, Theresa Chisolm PhD, Haley Neil, AuD
• Clinicaltrials.gov: NCT05070429

ACHIEVE BHFU

Brain Health Follow-Up Study, Long-Term Effects of Hearing Intervention on Brain Health in the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized study– (ACHIEVE Brain Health) 

• NIH/NCDID 1R01AG076518-01
• 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.
• Enrollment: Pending. The ARCT lab is a quality control site for this trial. Enrollment will not take place at our site. ·      
• USF Principal Investigator: Victoria Sanchez AuD PhD
• USF Study Team Members: Michelle Arnold AuD PhD, Theresa Chisolm PhD, Haley Neil, AuD, Sarah Bochat AuD, Sally Selevan
• Clinicaltrials.gov: NCT05532657

ACHIEVE EARLHI

Early-Stage Age Related Hearing Loss Investigation: A Pilot Study to asses mechanisms linking early Age-Related Hearing Loss and Alzheimer’s Disease and Related Dementias

• NIH/NCDID 1R01AG075083-01A1
• The target risk group is 55-75-year old people with early-stage age-related hearing loss (ARHL) and amnestic mild cognitive impairment. The RCT, entitled “Early Age-Related Hearing Loss Investigation (EARHLI).  The mechanisms linking ARHL and Alzheimer’s Disease and Related Dementias (AD/ADRD) are unknown, but reduced social engagement and changes in brain organization/connectivity have been proposed. EARHLI focuses on early ARHL in middle and early older age, a critical time for AD/ADRD prevention. Unlike ACHIEVE, EARHLI also measures brain organization/connectivity. EARHLI will be a phase II 1:1 RCT of a hearing aid-based intervention versus a comparator (health education program) conducted over 12 months in 150 participants (n=76 undergoing MRI) with early ARHL at risk for AD/ADRD. The overarching hypothesis is that the hearing intervention will lead to improved social engagement and brain organization/connectivity that will lead to improved cognition compared with the comparator arm. This hypothesis will be tested with an intent- to-treat approach comparing the hearing intervention and comparator arms. Aim 1 is to compare change in cognitive performance measured with the Alzheimer’s Disease Cooperative Study Preclinical Alzheimer Cognitive Composite (ADCS-PACC; 1º outcome) and by domain-specific cognitive testing on ADCS-PACC components (0, 6, 12 months). Aim 2 is to compare change in social engagement measured by activity participation (1º outcome) and network size/support (at 0, 6, 12 months). Aim 3 is to compare changes in brain organization/connectivity using task (visual task, auditory regions of interest,1º outcome) and resting-state fMRI, and diffusion-weighted structural connectivity (at 0, 12 months). We will explore whether social engagement and brain organization/connectivity mediate the effects of the intervention on cognitive outcomes.
• Enrollment: Active. The ARCT lab is a pilot study site and quality control site for this trial.
• USF Principal Investigator: Victoria Sanchez, AuD PhD
• USF Study Team Members: Theresa Chisolm PhD, Michelle Arnold AuD PhD,  Haley Neil AuD, Morgan Oktela Fuentes AuD, Suzannah Boyle BS, Sarah BoChat AuD, Sally Selevan
• Clinicaltrials.gov: NCT05532657

Development and Assessment of Spanish-Language Toolkit for Hearing Loss Self-Management

• NIH/NIDCD R21DC018655
• The purpose of the study is to develop and test Spanish-language patient education materials for hearing loss. First, we want to find out what people who speak Spanish think should go into these materials from focus groups. Next, we want to find out if people who speak Spanish have a better understanding of hearing loss and options for hearing loss help after receiving these.
• Enrollment: Active
• USF Principal Investigator: Michelle Arnold AuD PhD
• USF Study Team Members: Victoria Sanchez AuD PhD, Morgan Oktela Fuentes AuD , Haley Neil AuD, Marsadi Parliament AuD, Charity Lewis, Suzannah Boyle BS, Cruz Reyes BS, Madison Dowdy BS, Arianna Bartolome BS, Brijhan Burke, Sally Selevan
• Clinicaltrials.gov: NCT04534387

A Randomized, Double-Blind, Placebo-Controlled Phase ½ Study of OTO-413 Given as a Single Intratympanic Injection in Subjects with Speech-in-Noise Hearing Impairment

• Sponsor: Otonomy, Inc.
• The purpose of this study is to test the safety of the investigational product, OTO-413, compared to placebo (no active ingredient)in people with a type of hearing loss that makes it difficult for them to hear in noisy situations. OTO-413 contains the active ingredient brain-derived neurotrophic factor (BDNF). BDNF is a protein that is found in the body and helps nerve cells grow and survive. When OTO-413 is injected into the ear, OTO-413 turns into a gel and allows the BDNF to stay in the ear for several weeks. The ingredient that turns OTO-413 into a gel is called poloxamer 407.
• Enrollment: Concluded
• USF Principal Investigator: Victoria Sanchez AuD PhD
• USF Study Team Members:  K. Paul Boyev MD, Michelle Arnold AuD, Morgan Oktela Fuentes AuD, Haley Neil AuD, Marsadi Parliament AuD, Claire Dorey AuD, Charity Lewis MA, Suzannah Boyle BS, Cruz Reyes BS
• Clinicaltrials.gov: NCT04129775

A Phase 2, Prospective, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Multicenter Study to Evaluate the Efficacy of FX-322 Administered by Intratympanic Injection in Adults with Acquired Sensorineural Hearing Loss

• Sponsor: Frequency Therapeutics
• There is currently no drug treatment or cure for SNHL. Frequency Therapeutics, Inc. has begun a research study to gather additional information about an investigational drug called FX-322. FX-322 is a combination of two small molecule drugs that has been developed to potentially restore the hearing hair cells of the inner ear and thus possibly improve hearing.
• Enrollment: Concluded
• USF Principal Investigator: Victoria Sanchez AuD PhD
• USF Study Team Members: Julia Toman MD, K. Paul Boyev MD, Michelle Arnold AuD, Morgan Oktela Fuentes AuD, Haley Neil AuD, Marsadi Parliament AuD, Claire Dorey AuD, Charity Lewis MA, Suzannah Boyle BS, Cruz Reyes BS, Lauren Rosado BS
• Clinicaltrials.gov: NCT05086276

Hearing Health Knowledge, Attitudes, and Beliefs among Black Women: A Multi-method Analysis

• USF Health Internal Award
• To identify knowledge gaps regarding hearing loss and hearing healthcare among Black women and to determine whether the Health Belief Model (HBM) is an appropriate framework for exploring knowledge, attitudes, and beliefs about hearing loss and hearing healthcare among Black adults, particularly women
• Enrollment: Active
• USF Principal Investigator: Julia Toman MD
• Study Team Members: Victoria Sanchez AuD PhD, Michelle Arnold AuD PhD, Jaime Corvin PhD, Charity Lewis MA
• Clinicaltrials.gov: N/A

Auditory Ecology and its Relationship to Audiologic Intervention Outcomes in a Diverse Population Pilot Study

• Sponsor: Iowa University
• Pilot study to characterize auditory ecology and factors related to auditory ecology in a diverse sample and to gain insight on real-world communicative mass (e.g., speech understanding, listening effort) and how auditory ecology may influence hearing aid outcomes
• Enrollment: Active
• USF Principal Investigator: Michelle Arnold AuD PhD
• USF Study Team Members: Victoria Sanchez AuD PhD, Morgan Oktela Fuentes AuD, Sarah Bochat AuD, Cruz Reyes BS, Sally Selevan
• Clinicaltrials.gov: N/A

Community Pharmacies as sites for Over-the-Counter Hearing Aid Delivery; Stakeholder Opinions Pilot Study

• USF Principal Investigator-Initiated Research Study
• The purpose of the study is to gather opinions from pharmacists, technicians, audiologists, pharmacy and audiology students, and adults with age-related hearing loss (“stakeholders”) on over-the-counter (OTC) hearing aids. We are interested in learning how we might best design a training program for pharmacies to teach them about OTC hearing aids, so that providers and staff can help adult patients with hearing loss determine if an OTC hearing aid is right for them. The research will be carried using online/phone-based interviews or focus groups with stakeholders that will meet one time and last about 1.5 to 2 hours. An approved study team member will conduct the interviews. You will be able to choose whether you want to take part in an interview or a focus group.
• USF Principal Investigator: Michelle Arnold AuD PhD 
• USF Study Team Members: Victoria Sanchez AuD PhD, Morgan Oktela Fuentes AuD, Suzannah Boyle BS, Arianna Bartolome BS, Cruz Reyes BS, Sally Selevan
• Clinicaltrials.gov: N/A

Pilot Study to Evaluate the Long-term Chronic Care of Patients who could or do utilize an Osseointegrated Device (OID)

• USF Principal Investigator-Initiated Research Study
• Based on the ACHIEVE model, the purpose of this study is to evaluate the cognitive effects of OID hearing intervention among patients who could vs. do utilize an OID
• Enrollment: Active
• USF Principal Investigator: Victoria Sanchez, AuD PhD
• USF Study Team Members: K. Paul Boyev MD, Anthony Grady MD, Michelle Arnold AuD, Morgan Oktela Fuentes AuD, Marsadi Parliament AuD , Haley Neil AuD,, Claire Dorey AuD, Charity Lewis MA, Suzannah Boyle BS
• Clinicaltrials.gov: NCT04899037

Evaluation of Hearing Tests

• USF Principal Investigator -Initiated Research Study
• We will evaluate several types of hearing tests among subjects with sensorineural hearing loss and normal hearing to guide clinical guidelines.
• Enrollment: Active
• USF Principal Investigator: Victoria Sanchez, AuD PhD
• USF Study Team Members: Morgan Oktela Fuentes AuD, Marsadi Parliament AuD, Claire Dorey AuD, Suzannah Boyle BS, Arianna Bartolome BS

3 Ototoxicity Monitoring Studies: STELLAR, SWOG, and TIP

• USF Principal Investigator - Initiated Research Study
• Chemotherapy and anti-cancer therapeutic agents may cause many adverse side effects on patients. Some of these adverse effects include peripheral neuropathy (PN), hearing loss (HL) and cognitive impairment (CI). Although the negative adverse effects are known, there is a paucity of evidence on early detection and real-time monitoring of these adverse side effects during chemotherapy treatment.
• USF Principal Investigator: Victoria Sanchez, AuD PhD
• USF Study Team Members: Jennessa Rooker RN, Morgan Oktela Fuentes AuD and Suzannah Boyle BS