The SeaSHeL National Prospective Cohort Study (SeaSHeL)
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|ClinicalTrials.gov Identifier: NCT04108598|
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : July 21, 2020
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:
- Establish the patient pathway for patients presenting with SSNHL in the NHS
- Develop a tool that will help predict recovery for patients with idiopathic SSNHL.
- Establish the impact of idiopathic 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|
|Study Type :||Observational|
|Estimated Enrollment :||730 participants|
|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 :||May 1, 2022|
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
- 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:
- Full recovery: Final PTA in affected ear within 10dB of PTA of unaffected ear (≤10dB)
- Partial to no recovery: Final PTA in affected ear ≥ 10dB of PTA of unaffected ear.
- 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)
- 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).
- 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).
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
|Contact: Rishi Mandaviaemail@example.com|
|Contact: Yaamini Premakumarfirstname.lastname@example.org|
|London, United Kingdom|
|Contact: Yaami Premakumar email@example.com|
|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|