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Listen Carefully: An Exploratory Study of the Association Between Listening Effort and Cognitive Function

NCT04593290 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-04-28

No results posted yet for this study

Summary

This study aims to investigate the association between listening effort and cognitive function for both cognitively healthy individuals and for patients with Mild Cognitive Impairment (MCI) in mid-to-late stages of life, and furthermore to investigate listening effort and cognitive function after several weeks of hearing aid use. Listening effort is measured by the recording of peak pupil dilation during a sentence-final word identification and recall (SWIR) test, cognitive performance is measured using a battery of pen and paper cognitive tests, and hearing loss is measured with pure tone audiometry (PTA). A select number of participants in both the cognitively healthy and MCI group will be administered hearing aids, and the study will re-test both listening effort and cognitive performance.

Conditions

Interventions

DEVICE

Oticon Opn S 1 miniRITE hearing aid

Everyone who participates in Part 1 (listening effort testing and cognitive testing) will be invited to participate in Part 2 (hearing aids). It is not a requirement to participate in the administration, 6-week use, and re-testing procedures involved in Part 2 of the study. All cognitively healthy participants will be invited to participate, only MCI patients with a live-in informant will be given this opportunity. After ear measurement and dome and wire length selection, Oticon Opn S 1 miniRITE hearing aid fitting will occur wirelessly using Genie software, followed by hearing aid use instructions. The fitting will use Open domes, the standard NAL-NL2 protocol, and will increase gain seven steps on top of Real Ear Unaided Gain (REUG) from 750 Hz to 6 kHz.

Sponsors & Collaborators

  • Danish Dementia Research Centre

    collaborator NETWORK

  • Technical University of Denmark

    lead OTHER

Principal Investigators

  • Anja Maier, Ph.D. · DTU - Technical University of Denmark

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-08
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04593290 on ClinicalTrials.gov