Validation of the LEQ-CI
Research type
Research Study
Full title
Validation of the Listening Effort Questionnaire - Cochlear Implant (LEQ-CI): A new patient- reported outcome measure (PROM) of perceived listening effort in adult cochlear implant candidates and recipients
IRAS ID
251159
Contact name
Sarah Hughes
Contact email
Sponsor organisation
Abertawe Bro Morgannwg University (ABMU) Health Board
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
This study aims to find out how well a new questionnaire measures listening effort in adults with hearing loss who use a cochlear implant (CI). A CI is a device that is implanted into the inner ear that provides a sensation of sound when worn with an external speech processor. Listening effort is how hard a person must work to understand speech and other sounds. There are no clinical tools are available to assess everyday listening effort.
The new questionnaire is called the Listening Effort Questionnaire – Cochlear Implant (LEQ-CI). This study will prepare the LEQ-CI for clinical use. The study aims to: 1) refine the questionnaire’s design and 2) assess how accurately and reliably the LEQ-CI measures listening effort – a process called validation.
The study has two phases.
In Phase 1, the LEQ-CI and a demographic questionnaire will be posted to adults (n = 250) who are patients at NHS cochlear implant centres. Participants will be identified by their clinical team. Participation is voluntary. Participants will complete and return the questionnaires directly to the study team. No identifiable information will be collected. Once a person has returned their completed questionnaires they will no longer be involved in the study.
The participants’ responses will be entered into a database held at Swansea University. Different statistical tests will be completed. These tests show how well the LEQ-CI measures listening effort and whether changes need to be made to the LEQ-CI’s design. A revised version of the LEQ-CI will be produced.
Phase 2: The revised LEQ-CI will be tested using the same procedures. In Phase 2, a new sample of patients (n = 100) will complete the refined LEQ-CI plus three other questionnaires and post them back to the study team. The responses will be analysed statistically to establish the LEQ-CI’s construct validity. Construct validity is a measure of how well the LEQ-CI measures listening effort.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
18/NE/0320
Date of REC Opinion
5 Oct 2018
REC opinion
Favourable Opinion