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The SeaSHeL National Prospective Cohort Study

NCT04108598 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 730

Last updated 2020-07-21

No results posted yet for this study

Summary

Each year, approximately 15,000 people in the United Kingdom experience sudden loss of hearing that is sensorineural in nature. In the majority of cases, the cause is unknown despite investigation, and these cases are termed idiopathic 'sudden onset sensorineural hearing loss' (SSNHL). Treatment options for idiopathic SSNHL mainly include steroid treatments, with considerable limitations in their effectiveness and evidence base.

There are a number of new treatments being developed for idiopathic SSNHL based upon recent discoveries in underlying molecular mechanisms. These treatments require rigorous testing in clinical trials before they can become available for clinical use. To allow for such trials to be run effectively, there is an urgent need for information on patient numbers, geographical distribution, demographics, patient and treatment pathways, as well as outcomes.

This study proposes to collect these data through an ENT trainee and Audiologist led nationwide prospective cohort study of adult patients presenting with SSNHL within the National Health Services (NHS). The study will take place at 97 NHS sites across England with Ear, Nose, and Throat (ENT) and Audiology services.

Data once collected will be analysed to:

1. Establish the patient pathway for patients presenting with SSNHL in the NHS
2. Develop a tool that will help predict recovery for patients with idiopathic SSNHL.
3. Establish the impact of idiopathic SSNHL on people's quality of life.

Conditions

  • Sensory Hearing Loss
  • Sensorineural Hearing Loss
  • Sensorineural Hearing Loss in Left Ear
  • Sensorineural Hearing Loss in Right Ear
  • Sensorineural Hearing

Interventions

OTHER

Quality of life questionnaire

No intervention will be administered, select sites will administer a quality of life questionnaire

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Anne GM Schilder · Director NIHR UCLH Biomedical Research Centre Hearing Theme & evidENT

  • Rishi Mandavia · NIHR CLAHRC BRC Clinical Research Fellow ENT Surgery

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2021-03-30
Completion
2022-05-01

Countries

  • United Kingdom

Study Locations

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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 NCT04108598 on ClinicalTrials.gov