The SeaSHeL National Prospective Cohort Study

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Brief Title

The SeaSHeL National Prospective Cohort Study

Official Title

Prognostic Factors for Outcomes of Idiopathic Sudden Onset Sensorineural Hearing Loss

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.
    

Detailed Description

      Each year, approximately 20 people per 100,000 experience sudden loss of hearing that is
      sensorineural in nature. 'Sensorineural' indicates an abnormality of the cochlea, the
      auditory nerve, or higher central auditory pathways. When the hearing loss is of 30 dB
      (decibel) or more, over at least 3 contiguous frequencies and within 3 days, the condition is
      termed sudden onset sensorineural hearing loss (SSNHL). SSNHL is predominantly unilateral and
      the hearing loss can range from mild to profound. In 71% to 90% of cases, the cause is
      unknown despite investigation, and these cases are termed idiopathic.

      Associated symptoms include tinnitus, vertigo and aural fullness. Idiopathic SSNHL is a
      serious condition, adversely impacting people's lives with research indicating associations
      with emotional distress, depression, difficulties at work and impaired social integration. It
      is estimated that 32% to 65% of cases of idiopathic SSNHL recover spontaneously, although
      clinical experience suggests that this may be an overestimation, with further research
      required in this area.

      Current care pathways for patients suffering from idiopathic SSNHL appear to vary
      considerably in terms of the type of service patients first present to, their subsequent
      referral, length of time between onset of symptoms, presentation and start of treatment, the
      treatment plan as well as follow-up. Treatment options for idiopathic SSNHL include systemic
      and intratympanic steroids, antiviral agents, rheological agents, diuretics, hyperbaric
      oxygen treatment, and observation alone. The lack of evidence regarding the comparative
      effectiveness of these treatments is recognised by clinical guidelines published by National
      Institute for Health and Care Excellence (NICE), the American Academy of Otolaryngology-Head
      and Neck Surgery (ORL-HNS), and the British Academy of Audiology.

      Based upon recent discoveries in the molecular mechanisms that lead to sensorineural hearing
      loss, biotechnology and pharmaceutical companies are developing new treatments for patients
      with idiopathic SSNHL. These treatments require rigorous testing in clinical trials before
      they can become available for application in a clinical service setting. To allow for such
      trials to be run effectively reliable information is required on where patients with
      idiopathic SSNHL present and can be recruited from within the optimum timeframe from onset of
      symptoms to start of treatment based upon the preclinical profile of the drug. This means
      that 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 NHS.
      Importantly, this study will not only provide key data to inform future trial design and
      delivery, but also a unique dataset to develop a prediction model to predict recovery for
      patients with SSNHL.

      OBJECTIVES

        1. To map the patient pathway and identify the characteristics of adult patients presenting
           to NHS ENT and hearing services with SSNHL.

        2. To develop a prediction model to predict recovery for patients with SSNHL.

        3. Establish the impact of idiopathic SSNHL on patients' quality of life (QoL)

      METHODS

      Study design National multicentre prospective observational cohort study.

      Setting A multicentre study taking place at NHS centres providing ENT and Hearing Services.

      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.

      Primary outcome:

      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 outcomes:

      Degree of change in auditory function:

        -  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)

      Quality of life (QoL):

      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) and the Health Utility Index Mark 3 (HUI3). QoL
      data will be only be collected in a selection of sites (see below).

      Ranges for HHIA and HHIE are from 0 (no handicap) to 100 (total handicap) Range for HUI3 = 8
      (no handicap) to 45 (total handicap).

      Statistical analysis

      Prognostic model:

      The investigators will develop a multivariable prognostic model to predict recovery for
      patients with SSNHL in NHS ENT and Hearing services. Missing outcome data at study end will
      be imputed using multiple imputation by a chained equations procedure. Internal validation
      will be performed to quantify optimism in the predictive performance (calibration and
      discrimination) of the developed model using bootstrapping techniques. Bootstrapping
      techniques provide information on the performance of the model in comparable datasets and
      generate a shrinkage factor to adjust the regression coefficients.Statistical analysis will
      be carried out using R software (version 3.5.1).

      QoL:

      The mean change in HHIA, HHIE and HUI3 scores will be calculated from initial presentation to
      follow up (any one time between 6 and 16 weeks). The investigators will use the
      non-parametric Wilcoxon and McNemar-Bowker tests with a significance level of 5% to compare
      results at patients' initial presentation and at their final follow up. Statistical data
      analysis will be carried out using the SPSS program 19.0 (SPSS, Chicago, IL, USA). QoL data
      will be collected from a sub-set of sites (20%, n=20).
    


Study Type

Observational


Primary Outcome

Change in auditory function

Secondary Outcome

 Degree of change in auditory function

Condition

Sensory Hearing Loss

Intervention

Quality of life questionnaire

Study Arms / Comparison Groups

 Adults presenting with SSNHL
Description:  Adults presenting with SSNHL to NHS

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

550

Start Date

October 7, 2019

Completion Date

March 30, 2021

Primary Completion Date

March 30, 2021

Eligibility 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.
      

Gender

All

Ages

16 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Anne GM Schilder, 07947643912, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT04108598

Organization ID

124643


Responsible Party

Sponsor

Study Sponsor

University College, London


Study Sponsor

Anne GM Schilder, Principal Investigator, Director NIHR UCLH Biomedical Research Centre Hearing Theme & evidENT


Verification Date

March 2020