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The SeaSHeL National Prospective Cohort Study (SeaSHeL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04108598
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief 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 SSNHL.
  3. Establish the impact of SSNHL on people's quality of life.

Condition or disease Intervention/treatment
Sensory Hearing Loss Sensorineural Hearing Loss Sensorineural Hearing Loss in Left Ear Sensorineural Hearing Loss in Right Ear Sensorineural Hearing Other: Quality of life questionnaire

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Factors for Outcomes of Idiopathic Sudden Onset Sensorineural Hearing Loss
Actual Study Start Date : October 7, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Adults presenting with SSNHL
Adults presenting with SSNHL to NHS
Other: Quality of life questionnaire
No intervention will be administered, select sites will administer a quality of life questionnaire




Primary Outcome Measures :
  1. Change in auditory function [ Time Frame: 6 to 16 weeks from onset of symptoms ]

    The change in auditory function in the affected ear from initial presentation to follow-up (at any one time between 6 and 16 weeks from onset of symptoms). Auditory function will be defined as the Pure Tone Average (PTA) of air conduction thresholds at 250, 500, 1000, 2000, 4000 and 8000 Hz. If multiple pure tone audiograms have been carried out between 6 and 16 weeks, the most recent pure tone audiogram will be used for the calculation of auditory function.

    Change in auditory function classified as:

    1. Full recovery: Final PTA in affected ear within 10dB of PTA of unaffected ear (≤10dB)
    2. Partial to no recovery: Final PTA in affected ear ≥ 10dB of PTA of unaffected ear.


Secondary Outcome Measures :
  1. Degree of change in auditory function [ Time Frame: 6 to 16 weeks from onset of symptoms ]
    Complete recovery: Final PTA in affected ear within 10dB of PTA of unaffected ear (≤10dB) Marked recovery: PTA improvement ≥30 dB (and final PTA in affected ear ≥ 10dB of PTA of unaffected ear) Slight recovery: PTA improvement ≥10dB and <30 dB (and final PTA in affected ear ≥ 10dB of PTA of unaffected ear) No improvement: PTA improvement <10 dB (and final PTA in affected ear ≥ 10dB of PTA of unaffected ear)

  2. Quality of life using Hearing Handicap Inventory [ Time Frame: 6 to 16 weeks from onset of symptoms ]
    Change in QoL score from initial presentation to follow-up at any one time between 6 and 16 weeks following treatment. QoL will be measured using the Hearing Handicap Inventory for Adults (HHIA) (for patients under 60 years of age) or Hearing Handicap Inventory for Elderly (HHIE) (for patients over 60 years of age) . QoL data will be only be collected in a selection of sites(n=20).

  3. Quality of life using Health Utility Index 3 [ Time Frame: 6 to 16 weeks from onset of symptoms ]
    Change in QoL score from initial presentation to follow-up at any one time between 6 and 16 weeks following treatment. QoL will be measured using the Health Utility Index Mark 3 (HUI3). QoL data will be only be collected in a selection of sites(n=20).



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All adults who meet the inclusion criteria presenting to NHS services
Criteria

Inclusion Criteria:

  • Adult patients (male or female) aged over 16 years of age presenting to NHS ENT and hearing services with SSNHL AND
  • Diagnosed with a hearing loss in one or both ears of 30 dB HL or more, over at least 3 contiguous frequencies, between 250, 500, 1000, 2000, 4000 and 8000 Hz.

AND

• Willing and able to provide written informed consent.

Exclusion Criteria:

  • Patients with mixed or conductive hearing loss (CHL). CHL will be defined as a 'true' air-bone gap of 15 dB HL or more in 3 or more contiguous frequencies between 500, 1000, 2000, 4000 Hz.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04108598


Contacts
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Contact: Rishi Mandavia 07947643912 seashelstudy@gmail.com
Contact: Yaamini Premakumar seashelstudy@gmail.com

Locations
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United Kingdom
UCL Recruiting
London, United Kingdom
Contact: Yaami Premakumar       seashelstudy@gmail.com   
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Anne GM Schilder Director NIHR UCLH Biomedical Research Centre Hearing Theme & evidENT
Study Director: Rishi Mandavia NIHR CLAHRC BRC Clinical Research Fellow ENT Surgery
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04108598    
Other Study ID Numbers: 124643
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
Otolaryngology
Sudden onset sensorineural hearing loss
Sensorineural hearing loss
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms