[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04513782":3,"trial-entities:NCT04513782":100,"trial-summary:NCT04513782":104},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":16,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":31,"secondary_outcomes":42,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":66,"locations":69,"central_contacts":90,"overall_officials":94,"references":98,"see_also_links":99},"NCT04513782","19-1213","The Contributions of Age Related Changes in the Sound Localization Pathway to Central Hearing Loss","UNKNOWN","2026-05-29","2023-08","2023-08-15","2020-10-01","University of Colorado, Denver","OTHER",false,"Age-related hearing loss, presbycusis, affects up to 50% of American adults. There are two main causes for presbycusis: 1) Progressive death of hair cells in the inner ear, and 2) Central hearing loss, or the reduced ability to decipher the sound source of interest from other competing sounds in a multi-source complex environment. The first cause is better understood and treatment options, such as hearing aids and cochlear implants, are available. However, central hearing loss is not as well understood and there is not a treatment available at this time. This study aims to advance our understanding of central hearing loss by evaluating the abilities of younger and older listeners in two primary outcome measures: to 1) neurologically process sound stimuli and 2) focus on conversational speech in the presence of spatially-separated competing background noise. A test using Auditory Brainstem Responses (ABR) will be used to evaluate the brain's response to clicking sounds.\n\nThis study will assess all waveform data, but will focus particularly on wave III. Sentence in noise tests will be used to assess each subject's ability to process speech in noisy situations. Both the ABR and sentence in noise tests are non-invasive and are commonly used in audiology practices to diagnosis and treat a variety of audiological pathologies.",null,[18,19],"Healthy Individuals","Hearing Loss, Central",[],"OBSERVATIONAL",[],{"count":24,"type":25},200,"ESTIMATED",[27],{"type":28,"name":29,"description":30},"DIAGNOSTIC_TEST","Audiological Assessments","Participants will all undergo routine audiological assessments. The results from these assessments will be evaluated in order to advance understanding of central hearing loss.",[32,36,39],{"measure":33,"description":34,"timeFrame":35},"Speech in Noise Performance","Auditory perception task requiring participants to discriminate speech sound in quiet and in back ground noise. Takes about 90min.","through study completion, an average of 6 years",{"measure":37,"description":38,"timeFrame":35},"Auditory Brainstem Response","Non-invasive auditory electrophysiological measure of brainstem electrical activity captured using electrodes placed on the scalp while sounds are played to one or both ears. Takes about 60min",{"measure":40,"description":41,"timeFrame":35},"Spatial Acuity","Auditory perception task requiring participants to judge the location of a sound. Takes about 90min",[43,46,49,52,55],{"measure":44,"description":45,"timeFrame":35},"Working Memory Assessment","Reading span test to understand working memory capacity. Takes about 20min",{"measure":47,"description":48,"timeFrame":35},"Electrocorticogram","Non-invasive auditory electrophysiological measure of brainstem electrical activity captured using electrodes placed on the scalp while sounds are played to one or both ears. Takes about 45min.",{"measure":50,"description":51,"timeFrame":35},"Subject Questionnaires","Questionnaires administered to subject to gather information on health and hearing history, noise exposure, everyday listening. Takes about 30min.",{"measure":53,"description":54,"timeFrame":35},"TFS-AF","Two-alternative forced choice auditory perception task requiring participants to determine which sound has been modified. Takes about 20min.",{"measure":56,"description":57,"timeFrame":35},"Spectrotemporal Modulation","Two-alternative forced choice auditory perception task requiring participants to determine which sound has been modified. Takes about 30min","ALL","40 Years","89 Years",true,{"inclusion":63,"exclusion":64,"raw_text":65},[],[],"Inclusion Criteria:\n\n1. Subjects age ranges\n\n   a. 21 years (inclusive) and 89years (inclusive)\n2. Subjects exhibiting no poorer than a mild hearing loss, defined as hearing thresholds no worse than 40dBHL at any test frequency 250-4000 Hz based on pure tone audiometry\n3. Subjects scoring 26 or higher on a screening measure of cognitive status (Montreal Cognitive Screening Assessment; MoCA)\n\nExclusion Criteria:\n\n1. Patients outside the age range of 21-89\n2. Patients with an air-bone gap greater than 10dBHL at any frequency\n3. Patients who are decisionally challenged and\u002For unable to complete speech perception testing. These patients are excluded based on the study requiring behavioral responses to some tests\n4. Patients with little command of the English language who are unable to understand and repeat back simple everyday English sentences.\n5. Illiterate patients\n6. Patients with neurodegenerative diseases.",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":87},"University of Colorado School of Medicine","RECRUITING","Aurora","Colorado","80045","United States",[78,83],{"name":79,"role":80,"phone":81,"email":82},"Laura Temple","CONTACT","303-724-8465","laura.temple@cuanschutz.edu",{"name":84,"role":80,"phone":85,"email":86},"Kristi Engle-Folchert","303-724-9528","kristi.englefolchert@cuanschutz.edu",{"lat":88,"lon":89},39.72943,-104.83192,[91],{"name":92,"role":80,"phone":81,"email":93},"Shaylene Denham","shaylene.denham@cuanschutz.edu",[95],{"name":96,"affiliation":12,"role":97},"Daniel Tollin, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":101,"biomarkers":103},[18,102],"Hearing Loss",[],{"nct_id":4,"found":61,"summary":105,"prompt_version":115},{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This is an observational study with a planned enrollment of 200 participants. It is not a treatment study, but rather aims to understand central hearing loss.","completed","Observational Study on Age-Related Central Hearing Loss","This observational study aims to better understand central hearing loss, which is when your brain has trouble understanding sounds, especially in noisy places. Unlike other types of hearing loss, central hearing loss doesn't have a clear treatment yet. Researchers will use routine audiological assessments (hearing tests) to evaluate how younger and older individuals process sounds and focus on conversations. The study is looking for 200 participants between 40 and 89 years old who have no worse than mild hearing loss and score well on a cognitive screening. Success will be measured by how well participants perform on speech-in-noise tests, brainstem response tests, and spatial hearing tests over an average of 6 years.","Participants will be followed for an average of 6 years, with measurements taken throughout this period.",112,"You would undergo routine audiological assessments. These assessments will be evaluated to help researchers understand central hearing loss.","Not stated in the trial record.",[29],"v2"]