Listen Carefully protocol: an exploratory case–control study of the association between listening effort and cognitive function

INTRODUCTION: A growing body of evidence suggests that hearing loss is a significant and potentially modifiable risk factor for cognitive impairment. Although the mechanisms underlying the associations between cognitive decline and hearing loss are unclear, listening effort has been posited as one of the mechanisms involved with cognitive decline in older age. To date, there has been a lack of research investigating this association, particularly among adults with mild cognitive impairment (MCI). METHODS AND ANALYSIS: 15–25 cognitively healthy participants and 15–25 patients with MCI (age 40–85 years) will be recruited to participate in an exploratory study investigating the association between cognitive functioning and listening effort. Both behavioural and objective measures of listening effort will be investigated. The sentence-final word identification and recall (SWIR) test will be administered with single talker non-intelligible speech background noise while monitoring pupil dilation. Evaluation of cognitive function will be carried out in a clinical setting using a battery of neuropsychological tests. This study is considered exploratory and proof of concept, with information taken to help decide the validity of larger-scale trials. ETHICS AND DISSEMINATION: Written approval exemption was obtained by the Scientific Ethics Committee in the central region of Denmark (De Videnskabsetiske Komiteer i Region Hovedstaden), reference 19042404, and the project is registered pre-results at clinicaltrials.gov, reference NCT04593290, Protocol ID 19042404. Study results will be disseminated in peer-reviewed journals and conferences.