The SeaSHeL National Prospective Cohort Study

NCT04108598 | Unknown

• 1 other identifier: 124643
• Study Type: observational
• Target: 730
• Locations: 1 country
• Sites: 1

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. 1.Establish the patient pathway for patients presenting with SSNHL in the NHS
2. 2.Develop a tool that will help predict recovery for patients with idiopathic SSNHL.
3. 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

Keywords

Otolaryngology; Sudden onset sensorineural hearing loss; Sensorineural hearing loss

Outcome Measures

Primary Outcomes (1)

• Change in auditory function

  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.

  6 to 16 weeks from onset of symptoms

Secondary Outcomes (3)

• Degree of change in auditory function

  6 to 16 weeks from onset of symptoms

• Quality of life using Hearing Handicap Inventory

  6 to 16 weeks from onset of symptoms

• Quality of life using Health Utility Index 3

  6 to 16 weeks from onset of symptoms

Study Arms (1)

Adults presenting with SSNHL

Adults presenting with SSNHL to NHS

Other: Quality of life questionnaire

Interventions

Quality of life questionnaire OTHER

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

Adults presenting with SSNHL

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adults who meet the inclusion criteria presenting to NHS services

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

UCL

London, United Kingdom

RECRUITING

Related Publications (1)

• Mandavia R, Hannink G, Ahmed MN, Premakumar Y, Chu TSM, Blackshaw H, Ferdous T, Mehta N, Manjaly J, Khan M, Schilder AG; SeaSHeL Collaborative. Prognostic factors for outcomes of idiopathic sudden sensorineural hearing loss: protocol for the SeaSHeL national prospective cohort study. BMJ Open. 2020 Sep 28;10(9):e038552. doi: 10.1136/bmjopen-2020-038552.

  PMID: 32988948 DERIVED

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne GM Schilder

  Director NIHR UCLH Biomedical Research Centre Hearing Theme & evidENT

  PRINCIPAL INVESTIGATOR

• Rishi Mandavia

  NIHR CLAHRC BRC Clinical Research Fellow ENT Surgery

  STUDY DIRECTOR

Central Study Contacts

Rishi Mandavia

CONTACT

07947643912; seashelstudy@gmail.com

Yaamini Premakumar

CONTACT

seashelstudy@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 30, 2019
• Study Start: October 7, 2019
• Primary Completion: March 30, 2021
• Study Completion: May 1, 2022
• Last Updated: July 21, 2020

Record last verified: 2020-07

Locations

GB (1)