[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656410":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":29,"studyPopulation":20,"armGroups":30,"interventions":42,"overallOfficials":51,"centralContacts":55,"locations":61,"responsibleParty":97,"collaborators":99,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":20,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":20,"enrollmentInfo":112,"targetDuration":20,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":128,"whyStopped":20,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Duke University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Revised Hearing Handicap Inventory (RHHI)","18-item questionnaire that assesses self-perceived hearing difficulty associated with social and emotional situations and is considered a hearing-related quality of life measure. Higher scores indicate MORE hearing difficulty. Administered unaided and aided. Scores range from 0 - 72.","Baseline (unaided), 4 weeks (aided with intervention 1), 4 weeks (after wash-out period, and unaided), and 4 weeks (aided with intervention 2)",[14,17],{"measure":15,"description":16,"timeFrame":12},"Abbreviated Profile of Hearing Aid Benefit (APHAB)","24-item questionnaire used to assess hearing problems in various listening environments (e.g., quiet, background noise, reverberation, and aversiveness to sound). Higher scores indicate greater hearing problems. Administered unaided and aided. Scores range from 1% to 99%.",{"measure":18,"description":19,"timeFrame":12},"Words in Noise (WIN) Test","35-word recognition in noise test with 5 words at each of the 7 signal-to-noise ratios that go from 24 dB SNR to 0 dB SNR in 4-dB decrements. The noise (six talker babble) is held constant with the level of the words varying to make up the SNRs. Listener repeats words in background noise of talkers where the words get progressively softer. Higher scores indicate more trouble hearing in noise. Administered unaided and aided. Scores range from 0dB to 24dB.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":27},"SINGLE",[28],"INVESTIGATOR","Participants will be randomly assigned to a hearing aid group and asked to wear a pair of hearing aids with a certain setting for 4 weeks, take a 4-week break, then wear hearing aids with a different setting for 4 weeks. Participants will complete several hearing-related assessments before and after each trial of hearing aids and share their experiences with each hearing aid setting. This study includes four research visits at a research laboratory at Duke University or The Ohio State University.",[31,38],{"label":32,"type":33,"description":34,"interventionNames":35},"Open-dome receiver-in-canal hearing aids","EXPERIMENTAL","Air-conduction receiver-in-canal (RIC) hearing aids with open domes, which have holes or vents that let natural sound and air pass into the ear canal.",[36,37],"Other: Signal-to-Noise Ratio Enhancement (SNR+)","Other: Signal-to-Noise Ratio Neutral (SNR-)",{"label":39,"type":33,"description":40,"interventionNames":41},"Closed-dome receiver-in-canal hearing aids","Air-conduction receiver-in-canal (RIC) hearing aids with closed domes, which have solid rubber with tiny or no vents to seal the ear.",[36,37],[43,47],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":20},"Signal-to-Noise Ratio Enhancement (SNR+)","Participants will be randomly assigned to either the open dome or closed dome group (Factor 1). Participants will then obtain their first treatment arm with a random assignment of either an SNR neutral (SNR-) or SNR enhanced (SNR+) hearing aid fitting (Factor 2). They will return to the lab for testing prior to crossing over to the second arm (the other SNR configuration: SNR- or SNR+).\n\nThe SNR+ setting contains features to improve the signal-to-noise ratio of the sound to optimize speech over noise through the hearing aids.",[39,32],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":20},"Signal-to-Noise Ratio Neutral (SNR-)","Participants will be randomly assigned to either the open dome or closed dome group (Factor 1). Participants will then obtain their first treatment arm with a random assignment of either an SNR neutral (SNR-) or SNR enhanced (SNR+) hearing aid fitting (Factor 2). They will return to the lab for unaided baseline testing prior to crossing over to the second arm (the other SNR configuration: SNR- or SNR+).\n\nThe SNR- setting contains focuses on improving audibility of sounds through the hearing aids.",[39,32],[52],{"name":53,"affiliation":5,"role":54},"Sherri L Smith, Au.D., Ph.D.","PRINCIPAL_INVESTIGATOR",[56],{"name":57,"role":58,"phone":59,"phoneExt":20,"email":60},"Jenny L Norris, MA","CONTACT","919-681-2137","jenny.l.norris@duke.edu",[62,81],{"facility":63,"status":20,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Duke University Medical Center","Durham","North Carolina","27710","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-78.89862,35.99403,{"lat":73,"lon":72},[76,77,80],{"name":57,"role":58,"phone":59,"phoneExt":20,"email":60},{"name":53,"role":58,"phone":78,"phoneExt":20,"email":79},"919-613-1110","sherri.smith@duke.edu",{"name":53,"role":54,"phone":20,"phoneExt":20,"email":20},{"facility":82,"status":20,"city":83,"state":84,"zip":85,"country":67,"countryCode":68,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"The Ohio State University","Columbus","Ohio","43210",{"type":70,"coordinates":87},[88,89],-82.99879,39.96118,{"lat":89,"lon":88},[92,96],{"name":93,"role":58,"phone":94,"phoneExt":20,"email":95},"Christina M Roup, Ph.D.","614-247-8614","roup.2@osu.edu",{"name":93,"role":54,"phone":20,"phoneExt":20,"email":20},{"type":98,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[100],{"name":101,"class":102},"National Institute on Deafness and Other Communication Disorders (NIDCD)","NIH","100656410","the-hear-clear-study-100656410",false,"NCT07824115","The Hear Clear Study","Hearing Aid Benefit in Adults With Self-Reported Hearing Difficulty Yet Normal Pure-Tone Audiograms (Duke sIRB)","Inclusion Criteria:\n\n* Are adults (≥18 years) presenting with \"normal hearing\" (pure-tone thresholds ≤25 dB HL from 250-4000 Hz) but hearing trouble (≥20 points on RHHI questionnaire)\n* Are willing to try amplification (i.e., hearing aids) for the first time\n* Can Read\u002Fwrite in American English\n* Have access to email, internet, and phone\n\nExclusion Criteria:\n\n* Participants with self-reported otologic history (e.g., ear surgery, ototoxic medications, middle-ear dysfunction, holes in ear drums)\n* Have moderate to severe traumatic brain injury\n* Have bothersome tinnitus as their primary complaint\n* Have a health condition that would interfere with study participation (e.g., dementia\u002Fcognitive disorder, blindness)\n* Prior hearing aid use","ALL","18 Years",{"count":113,"type":114},125,"ESTIMATED","INTERVENTIONAL",[117],"NA","The purpose of this study is to determine if hearing aid use helps adults with \"normal\" hearing on clinical hearing tests (i.e., pure-tone audiogram), but who report hearing trouble in everyday life. Another purpose is to understand what factors and hearing aid features provide the most help for these people.",[120],"Hearing Loss",[122,123,124,125,126,127],"normal pure-tone hearing","complaints of hearing difficulty","hearing aids","normal hearing","near-normal hearing","auditory processing","NOT_YET_RECRUITING","2026-09-16",{"date":131,"type":132},"2026-09-21","ACTUAL",{"date":134,"type":114},"2027-01",{"date":136,"type":114},"2030-05",{"name":5,"class":6},2]