[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592388":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":58,"collaborators":60,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":26,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Zealand University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group (IG)","EXPERIMENTAL","Remote Fine-Tuning of Hearing Aids Using Smartphone App",[13],"Device: Remote fine-tuning of hearing aids",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group (CG)","ACTIVE_COMPARATOR","Face-to-Face Fine-Tuning of Hearing Aids in Clinic",[19],"Device: Face-to-face fine-tuning of hearing aids",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Remote fine-tuning of hearing aids","Remote Fine-Tuning of Hearing Aids allows patients to adjust their hearing aids remotely, without having to visit a clinic. Using a mobile app on the patient's device, real-time adjustments are made based on their feedback, with immediate changes during the session.\n\nUnlike traditional face-to-face adjustments, this approach lets patients stay in their own familiar surroundings. This helps create a more accurate listening environment, as the adjustments are made based on the sounds they experience in their everyday life.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Face-to-face fine-tuning of hearing aids","In the clinic, the standard procedure for fine-tuning hearing aids (HAs) involves a face-to-face consultation with an audiologist, typically lasting 30 minutes.",[15],[32],{"name":33,"affiliation":5,"role":34},"Bjarki Ditlev Djurhuus, MD, PhD, Assoc Prof","STUDY_CHAIR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Nagehan Altinkaya, phD student","CONTACT","+4560625058","nagal@regionsjaelland.dk",{"name":42,"role":38,"phone":26,"phoneExt":26,"email":26},"Bjarki Ditlev Djurhuus",[44],{"facility":5,"status":45,"city":46,"state":26,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Køge","4600","Denmark","DK",{"type":51,"coordinates":52},"Point",[53,54],12.18214,55.45802,{"lat":54,"lon":53},[57],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":59,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[61],{"name":62,"class":6},"Interreg","100592388","effectiveness-and-acceptability-of-remote-fine-tuning-of-hearing-aids-in-danish-adults-100592388",false,"NCT06992778","Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults","Exploring the Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults: A Non-blinded, Non-inferiority Randomized Controlled Trial With an Embedded Qualitative Study","EARFit","Inclusion Criteria:\n\n* Adult patients with hearing loss who desire HA treatment (+18 of age).\n* Danish language skills both written and oral.\n* Acquisition of digital proficiency in terms of being familiar with operating a smartphone, including navigating menus, opening and closing apps, and interacting with the touchscreen with capabilities for audio and video calls.\n* Access to a smartphone that are compatible with manufacturers' system requirements.\n* Access to a stable network connection on the mobile device, with either Wi-Fi or mobile data.\n\nExclusion Criteria:\n\n* Patients with tinnitus requiring treatment or scoring more than 58 in the 'Tinnitus Handicap Inventory' (THI) grading system.\n* Patients with Ménière disease, due to its complications and symptoms as dizziness, balance problems and fluctuating hearing loss, that can affect the HA treatment.\n* Patients who will receive in-the-ear (ITE) hearing aids, due to potential limitations in connectivity for remote fine-tuning.\n* Patients which are recommended\u002Foffered unilateral HA treatment.","ALL","18 Years",{"count":74,"type":75},120,"ESTIMATED","INTERVENTIONAL",[78],"NA","The aim of this clinical trial is to evaluate the effectiveness and user satisfaction of remote fine-tuning of hearing aids compared to traditional face-to-face adjustments. The main questions aims to answer:\n\n\\- Are hearing aid outcomes (self-reported and objective) similar when using remote fine-tuning compared to face-to-face adjustments?\n\nResearchers will compare remote fine-tuning (using a smartphone app) to traditional face-to-face fine-tuning sessions in a clinical setting.\n\nParticipants will:\n\n* Be randomized to either the remote fine-tuning group (intervention group) or the face-to-face adjustment group (control group).\n* Attend five scheduled consultations over a 3-month period, including baseline measurements, hearing aid fittings, and follow-up visits.\n\nParticipants in the remote fine-tuning group will:\n\n\\- Set up and use a hearing aid manufacturer's smartphone app to complete fine-tuning sessions from home.\n\nParticipants in the face-to-face group will:\n\n\\- Visit the clinic for in-person fine-tuning appointments.\n\nData will be collected through questionnaires (e.g., SSQ-12, IOI-HA, and COSI) and objective measures such as the Speech Intelligibility Index (SII) and speech comprehension in noise (DS-FF). Additional qualitative data will be gathered from interviews with participants in the remote fine-tuning group.",[81,82,83,84],"Hearing Aid","Telehealth","Hearing Aid Fitting","Effectiveness",[86,87,88,89,48],"Remote fine-tuning","Teleaudiology","Randomized controlled trial (RCT)","Hearing aids","2025-08-13",{"date":92,"type":93},"2025-08-14","ACTUAL",{"date":95,"type":93},"2025-05-27",{"date":97,"type":75},"2026-03-30",{"name":5,"class":6},1]