The Auditory Rehabilitation and Clinical Trials (ARCT) Lab conducts studies in the areas of diagnostics, hearing health disparities, speech perception, cognition, and hearing rehabilitation through hearing aids and investigational medications. The ARCT Lab has been funded by the National Institute of Health for over 15 years.
The following are examples of funded projects:
Research Studies
Aging and Cognitive Health Evaluation in Elders (ACHIEVE)
NIH/NIA R01AG055426; ClinicalTrials.gov: NCT03243422
This study is a multi-site randomized controlled trial, where older adults with hearing loss are randomized to either a 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), and assessed semi-annually for 3 years. The ARCT lab designed the hearing intervention provided in the ACHIEVE Study and was responsible for intervention quality assurance and quality control.
Status: Closed
Enrollment: Closed
Hearing Intervention Follow-Up Study, Randomized Trial of Telehealth vs. Conventional Hearing Care Delivery in the ACHIEVE Study with Hearing Aid Users (ACHIEVE-HIFU)
NIH/NIDCD R01DC019408; Clinicaltrials.gov: NCT05070429
This study is a multi-site randomized controlled trial comparing conventional in-person hearing health care (HHC) vs. in-person HHC plus telehealth audiology sessions among existing hearing aid users with mild-to-moderate hearing loss. The ARCT Lab designed the hearing interventions (telehealth and conventional sessions), completed pilot studies, and was responsible for study quality assurance and control for this trial.
Status: Active
Enrollment: Closed
Brain Health Follow-Up Study (ACHIEVE-BHFU)
NIH/NCDID R01AG076518; Clinicaltrials.gov: NCT05532657
This study is a 3-year follow-up to the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized controlled study, with the specific aim 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. The ARCT Lab provides the intervention quality control for this trial.
Status: Active
Enrollment: Enrollment closed at study sites.
Early-Stage Age Related Hearing Loss Investigation (EARHLI)
NIH/NCDID R01AG075083; Clinicaltrials.gov: NCT06174038
The EARHLI study aims to evaluate the mechanisms linking early Age-Related Hearing Loss (ARHL) and Alzheimer’s disease and related dementias (AD/ADRD). EARHLI focuses on middle and older adults with ARHL and mild cognitive impairment, which is a critical time for AD/ADRD prevention. EARHLI is a Phase II 1:1 RCT of a hearing aid-based intervention vs. a comparator (health education program) conducted over 12 months, with focus on changes in brain organization/connectivity.
Status: Active
Enrollment: Open
Pilot Study for the Early-Stage Age Related Hearing Loss Investigation (PEARHLI)
NIH/NCDID R01AG075083; Clinicaltrials.gov: NCT05970211
This is a pilot study preparing for the EARHLI study that focuses on middle and older adults with ARHL and mild cognitive impairment, which is a critical time for AD/ADRD prevention. EARHLI is a Phase II 1:1 RCT of a hearing aid-based intervention vs. a comparator (health education program) conducted over 12 months, with focus on changes in brain organization/connectivity.
Status: Active
Enrollment: Closed
Pilot Study to Evaluate the Long-term Chronic Care of Patients who could or do utilize an Osseointegrated Device (OID)
Clinicaltrials.gov: NCT04899037
This is a pilot study that is based on the ACHIEVE model. The purpose of this study is to evaluate the long-term cognitive, physical, and psycho-social effects of OID hearing intervention among patients who could vs. do utilize an OID.
Status: Active
Enrollment: Open
Development and Assessment of Spanish-Language Toolkit for Hearing Loss Self-Management
NIH/NIDCD R21DC018655; Clinicaltrials.gov: NCT04534387
The purpose of the study is to develop and test Spanish-language patient education materials for hearing loss. Using focus groups, education materials will be developed, and then assessed with Spanish-speaking participants.
Status: Active
Enrollment: Closed
Hearing Health Knowledge, Attitudes, and Beliefs among Black Women: A Multi-Method Analysis
The purpose of the study is 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.
Status: Active
Enrollment: Closed
3 Ototoxicity Monitoring Studies: STELLAR, SWOG, and TIP
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.
Status: Concluded
Enrollment: Closed
Cross sectional and prospective study to characterize early-onset presbycusis (SONG)
Sponsor: Sensorion; Clinicaltrials.gov: NCT06354010
This is a multicenter, international, low-interventional, cross-sectional and prospective study that aims to characterize patients with adulthood-onset of bilateral sensorineural hearing loss (“early presbycusis”) likely due to a genetic cause rather than an underlying medical condition. No medicinal products or devices are administered or used, as the purpose is to assess the evolution of hearing loss in those carrying mutations in GJB2 gene through audiological and medical evaluations.
Status: Open
Enrollment: Recruiting
Intratympanic Injection in Subjects with Speech-in-Noise Impairment
Sponsor: Otonomy, Inc.; Clinicaltrials.gov: NCT04129775
This study is a randomized, double-blind, placebo-controlled phase ½ study of OTO-413, given as a single intratympanic injection in subjects with speech-in-noise impairment. The purpose is to test the safety of the investigational product, OTO-413, compared to placebo (no active ingredient) in people with speech-in-noise impairment. 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.
Status: Concluded
Enrollment: Closed
Intratympanic Injection in Adults with Acquired Sensorineural Hearing Loss
Sponsor: Frequency Therapeutics; Clinicaltrials.gov: NCT05086276
This study is a Phase 2, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter study. The aim is to evaluate the efficacy of FX-322, administered by intratympanic injection in adults with acquired sensorineural hearing loss. As there is currently no drug treatment or cure for sensorineural hearing loss, 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 inner ear hair cells and thus possibly improve hearing abilities.
Status: Concluded
Enrollment: Closed
Evaluation of Hearing Tests
This study aims to evaluate several types of hearing tests among subjects with sensorineural hearing loss and normal hearing to further guide clinical guidelines.
Status: Active
Enrollment: Open