MedTrace Logo

AI-assisted Diagnosis, Triage and Assessment of Hearing Loss and Tinnitus

NCT07586098 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2026-05-14

No results posted yet for this study

Summary

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.

To 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.

This 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.

If 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.

Conditions

  • Hearing Loss, Adult-Onset
  • Tinnitus

Interventions

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

Sponsors & Collaborators

  • University of Exeter

    collaborator OTHER

  • University of Birmingham

    collaborator OTHER

  • Royal Cornwall Hospitals Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2026-08-13
Completion
2027-08-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07586098 on ClinicalTrials.gov