Research

Past Studies

These studies are no longer accepting new participants. If you are interested in participating in other research studies in our lab or would like to be contacted for new studies, please call us at 813-974-1262.

Community Pharmacies as sites for Over-the-Counter Hearing Aid Delivery; Stakeholder Opinions Pilot 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-Initiated Research Study
  • USF Principal Investigator: Michelle Arnold AuD PhD  
  • Clinicaltrials.gov: N/A

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

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. 

  • Sponsor: Otonomy, Inc.
  • USF Principal Investigator: Victoria Sanchez AuD PhD
  • Clinicaltrials.gov: NCT04129775                                                                                                    

A Phase 2a, Prospective, Randomized, DoubleBlind, Placebo Controlled, Single and Repeat-Dose, Multicenter, Exploratory Efficacy Study of FX-322 Administered by Intratympanic Injection in Adults with Stable 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. 
  • USF Principal Investigator: Victoria Sanchez AuD PhD
  • Clinicaltrials.gov: NCT05086276                                                                                                      

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 

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.

  • NIH/NIDCD 1 R01 DC019408-01
  • The ARCT lab is a pilot study site and quality control site for this trial.
  • USF Principal investigator: Victoria Sanchez AuD PhD
  • 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 

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.

  • NIH/NIDCD 1 R01 DC019408-01
  • The ARCT lab is a pilot study site and quality control site for this trial.
  • USF Principal investigator: Victoria Sanchez AuD PhD
  • Clinicaltrials.gov: NCT05070429

Aging and Cognition Health Evaluation in Elders (ACHIEVE RCT)

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.

  • NIH/NIA 1 R01 AG055426-01
  • The ARCT lab is a quality control site for this trial. 
  • USF Principal Investigator:  Theresa Chisolm PhD
  • ClinicalTrials.gov: NCT03243422

Application of Health Behavior Models to Predict Hearing Healthcare Outcomes

To better understand the relationship between an adult's hearing health care behaviors and his/her attitudes and beliefs about hearing healthcare and readiness for behavior change 

  • USF Principal Investigator: Theresa Chisolm PhD

A Balanced, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss

This study aims to evaluate the efficacy of the drug AUT00063 (CLARITY-1) on the ability to understand speech in noisy environments

  • Enrollment: Concluded
  • USF Principal Investigator: Victoria Sanchez, AuD PhD 
  • Clinicaltrials.gov: NCT02345031

Project: Epidemiology of Diabetes Interventions and Complications (EDIC)

The primary mission of the EDIC study is to determine the effects of glycemic control and of non-hyperglycemic risk factors on the complications of type 1 diabetes. We are one of multiple sites in the nation collecting data for EDIC.

  • Enrollment: Concluded
  • USF Principal Investigator: Victoria Sanchez, AuD PhD
  • Clinicaltrials.gov: NCT00360893

Project: Audiologic Profile of Individuals with Friedreich's Ataxia

Within collaboration with USF Department of Neurology, this study aims to investigate the auditory behavioral and electro-physiological profile of individuals with Friedreich's Ataxia as part of a larger clinical drug trial

  • Enrollment: Concluded
  • USF Principal Investigator: Victoria Sanchez, AuD PhD
  • Clinicaltrials.gov: NCT0128064