[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641014":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":28,"locations":38,"responsibleParty":52,"collaborators":54,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":10,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":10,"enrollmentInfo":68,"targetDuration":71,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":86,"whyStopped":10,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Royal Cornwall Hospitals Trust","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1 - Patients undergoing the standard virtual hearing loss and tinnitus clinic",null,"Phase 1 consists of a retrospective and prospective observational evaluation of consecutive adult patients managed through the virtual hearing loss and tinnitus clinic at the Royal Cornwall Hospitals Trust, between August 2025 and August 2026. No additional interventions.",[13],"Device: Artificial Intelligence (AI) Assisted Clinical Decision Support Tool for managing Hearing Loss and Tinnitus",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 2 - Patients undergoing the AI-assisted virtual hearing loss and tinnitus clinic","Phase 2 consists of a prospective observational evaluation of consecutive adult patients managed through the AI-assisted virtual hearing loss and tinnitus clinic at the Royal Cornwall Hospitals Trust, between August 2026 and August 2027. The AI-assisted clinic is the intervention.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Phase 2 - Staff involved in providing an AI-assisted virtual hearing loss and tinnitus clinic","Staff involved in running the artificial intelligence-assisted virtual hearing loss and tinnitus clinic at the Royal Cornwall Hospitals Trust from August 2026 to August 2027. They include doctors, healthcare assistants, administrative staff and nurses. The AI-assisted clinic is the intervention.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DEVICE","Artificial Intelligence (AI) Assisted Clinical Decision Support Tool for managing Hearing Loss and Tinnitus","An explainable AI-based clinical decision support tool within an existing virtual hearing loss and tinnitus clinic. The tool provides non-binding triage and investigation recommendations based on routinely collected patient data, with all final clinical decisions remaining the responsibility of the clinician and no change to standard care pathways",[9,15,19],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Neil C Tan, MEd PhD FRCS(ORL-HNS)","CONTACT","+441872 253404","neil.tan@nhs.net",{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},"Christian JW Grimes, BMBS MRCS (ENT) PGCert ClinEd","+447970780502","christian.grimes@nhs.net",[39],{"facility":40,"status":10,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":10},"Treliske Hospital","Truro","Cornwall","TR1 1LJ","United Kingdom","UK",{"type":47,"coordinates":48},"Point",[49,50],-5.05436,50.26526,{"lat":50,"lon":49},{"type":53,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[55,57],{"name":56,"class":6},"University of Exeter",{"name":58,"class":6},"University of Birmingham","100641014","ai-assisted-diagnosis-triage-and-assessment-of-hearing-loss-and-tinnitus-100641014",false,"NCT07586098","AI-assisted Diagnosis, Triage and Assessment of Hearing Loss and Tinnitus","Artificial Intelligence for the Automated Diagnosis, Triage, and Assessment of Patients With Hearing Loss and Tinnitus: A Pilot Comparative Study With Clinical Evaluation by Otolaryngologists","Inclusion Criteria:\n\n* Patients assessed in the RCHT virtual hearing loss and tinnitus clinic.\n* Presenting symptoms of hearing loss and\u002For tinnitus.\n* Ability to provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Individuals under 18 years of age.\n* Patients unable to provide informed consent.\n* Patients without sufficient English proficiency where translation services cannot be arranged.\n* Cases where data quality is insufficient for analysis.","ALL","18 Years",{"count":69,"type":70},1500,"ESTIMATED","1 Year","OBSERVATIONAL","Hearing loss affects approximately 11 million people in the UK, while tinnitus impacts around 7 million. Both conditions can significantly reduce quality of life and are linked to poorer mental health and employment challenges. Each year, tinnitus alone accounts for more than one million GP appointments, and patients referred to hospital ear, nose and throat (ENT) services often face long delays, sometimes exceeding a year, before their first assessment.\n\nTo address this demand, the Royal Cornwall Hospitals NHS Trust has developed a virtual ENT clinic. Patients undergo a validated hearing test in person and complete online questionnaires. Clinicians then review these data to determine next steps, which may include discharge with advice, referral for imaging, or a face-to-face consultation. Initial trials demonstrated that the majority of patients could be managed virtually, substantially reducing waiting times. However, clinicians must still review every case, limiting capacity for patients who require direct care.\n\nThis project builds on the virtual clinic by introducing artificial intelligence (AI) to support the assessment process. Using explainable AI methods, the system will be trained to replicate clinician-level decision-making while providing transparent reasoning for its recommendations. The study will evaluate how closely AI-generated outcomes align with clinician assessments, with all cases continuing to receive a clinician's final review. Clinicians will not be aware of the recommendations produced by the AI tool, but the study aims to measure how concordant AI recommendations are with clinician assessments.\n\nIf the AI tool's clinical recommendations closely align with clinician recommendations (the gold standard for care), the AI tool could be introduced as a clinical recommendation assistant tool, streamlining the triage and management of hearing loss and tinnitus, enabling clinicians to focus on complex cases, accelerating access to care, and improving efficiency.",[75,76],"Hearing Loss, Adult-Onset","Tinnitus",[78,79,76,80,81,82,83,84,85],"Artificial Intelligence","Hearing Loss","Clinical Decision Support Systems","Computerized","Telemedicine","Otolaryngology","Patient Satisfaction","Feasibility Studies","NOT_YET_RECRUITING","2026-05-07",{"date":89,"type":90},"2026-05-14","ACTUAL",{"date":92,"type":70},"2026-05-30",{"date":94,"type":70},"2027-08-31",{"name":5,"class":6},1]