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

NCT04593290 | Completed

• 1 other identifier: 19042404
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Cognitive Impairment, Mild; Hearing Loss

Outcome Measures

Primary Outcomes (7)

• Listening effort

  Listening effort will be measured by the percent of correctly recalled words in the SWIR test and the time-bound pattern in the pupil dilation traces during the SWIR test.

  Baseline, pre-intervention

• The Stroop Color and Word test

  Neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. Measure: time (seconds) and number of mistakes. Increased time corresponds to poorer performance. Increased mistakes correspond to poorer performance.

  Baseline, pre-intervention

• Rey Complex Figure Test

  Neuropsychological assessment, administered by trained neuropsychologist, where examinees are asked to reproduce a complicated line drawing, first by copying it freehand and then drawing it from recall. This tests both recognition and recall, and uses visuospatial abilities, memory, attention, planning, working memory and executive functions. Measure: Accuracy scores between 0 and 2 on 18 figure elements (from 0 to a maximum of 36) on both copy and delayed recall Higher score = improved performance

  Baseline, pre-intervention

• Symbol-Digit Modalities Test

  Neuropsychological assessment commonly used in clinical and research settings to assess neurological dysfunction. The participant has 90 seconds to pair specific numbers with given geometric figures. Like other substitution tasks, performance is underpinned by attention, perceptual speed, motor speed, and visual scanning. Measure: Total score based on number of pairings made in 90 seconds ( maximum of 110 pairings). Higher score corresponds to improved performance.

  Baseline, pre-intervention

• Trail Making Test A and B

  Neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. Test A has participants follow numbers sequentially, while Test B has participants follow alternating numbers and letters, sequentially. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. Measure: Test A - total time (seconds) required to connect 25 numbers, Test B - total time (seconds) required to connect 13 numbers and alphabet to letter H. Increased time corresponds to poorer performance.

  Baseline, pre-intervention

• Verbal Fluency Test (category and lexical)

  Participants are given 1 minute to produce as many unique words as possible within a semantic category (category fluency) or starting with a given letter (letter fluency). Category fluency tasks rely on language representations of semantic concepts, whereas lexical and action word task rely more on the central executive component of working memory. Measure: Number of unique words identified within 1 minute. More words correspond to improved performance.

  Baseline, pre-intervention

• Logical Memory Test A

  The Logical Memory test (part A) is a subtest of the Wechsler Memory Scale-Revised, and is a standardised assessment of narrative episodic memory. A short story is orally presented and the examinee is asked to recall the story verbatim. 25-35 minutes later, free recall of the story is again elicited (delayed recall), and a series of 30 questions are asked about the story. Measure: scores between 0 and 1 on specific pieces of the story (maximum score of 25) in both immediate and delayed recall. For the questions, a score of 0 or 1 is given to the corresponding 30 questions (maximum score of 30). Higher score corresponds to improved performance.

  Baseline, pre-intervention

Secondary Outcomes (7)

• Listening effort post-hearing aid use

  Post-intervention, after 6 weeks of intervention (hearing aid use)

• Logical Memory Test A post-hearing aid use

  Post-intervention, after 6 weeks of intervention (hearing aid use)

• Verbal Fluency Test (category and lexical) post-hearing aid use

  Post-intervention, after 6 weeks of intervention (hearing aid use)

• Trail Making Test A and B - post-hearing aid use

  Post-intervention, after 6 weeks of intervention (hearing aid use)

• Symbol-Digit Modalities Test

  Post-intervention, after 6 weeks of intervention (hearing aid use)

Study Arms (2)

Mild Cognitive Impairment (MCI)

EXPERIMENTAL

MCI is defined as an early stage of cognitive decline that lies between normal age-matched cognitive function and the onset of very mild forms of dementia, and is associated with a slight but noticeable decline in abilities such as memory and thinking skills. Listening effort testing (with pupillometry) and cognitive testing will be administered for this group - and after a 6-week period of hearing aid use, these measures will be re-tested.

Device: Oticon Opn S 1 miniRITE hearing aid

Cognitively Healthy

ACTIVE COMPARATOR

This group is 40-85 years old and has no significant neurological or psychiatric disease. Listening effort testing (with pupillometry) and cognitive testing will be administered for this group - and after a 6-week period of hearing aid use, these measures will be re-tested.

Device: Oticon Opn S 1 miniRITE hearing aid

Interventions

Oticon Opn S 1 miniRITE hearing aid DEVICE

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.

Cognitively Healthy; Mild Cognitive Impairment (MCI)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is 40-85 years old;
• Has no other significant neurological or psychiatric disease;
• Has normal hearing (0 - 25 dB thresholds from 250 -6 kHz) measured using PTA;
• Has normal or corrected to normal vision;
• Has an MCI diagnosis, according to Winblad criteria, with a score on the Mini Mental State Examination (MMSE) less than or equal to 26 (MMSE ≤ 26);
• Has a CDR = 0.5;
• Speaks Danish as native language
• (For part 2 of the study - hearing aid use) has a live-in informant.

You may not qualify if:

• Takes medication or treatment that could impact the pupillary dilation: eye drops (e.g. atropine or phenylephrine);
• Takes medication or treatment that could impact cognitive function;
• Abuses alcohol or drugs;
• Is unable to comply with study procedures.
• Cognitively healthy group:
• Is 40-85 years old;
• Has a score above 26 on the Mini Mental State Examination (MMSE) (MMSE \> 26);
• Has a CDR Global score = 0;
• Has no significant neurological or psychiatric disease;
• Has Normal hearing (0 - 25 dB thresholds from 250 -6 kHz) measured using PTA;
• Has Normal or corrected to normal vision;
• Speaks Danish as a native language.
• Meets the criteria for MCI (Winblad criteria) or dementia (ICD 10);
• Takes medication or treatment that could impact the pupillary dilation: eye drops (e.g. atropine or phenylephrine);
• Takes medication or treatment that could impact cognitive function;

Sponsors & Collaborators

• Technical University of Denmark: lead
• Danish Dementia Research Centre: collaborator

Study Sites (1)

Copenhagen Memory Clinic, Rigshospitalet

Copenhagen, Region H, 2100, Denmark

Location

Related Publications (7)

• Pichora-Fuller MK, Kramer SE, Eckert MA, Edwards B, Hornsby BW, Humes LE, Lemke U, Lunner T, Matthen M, Mackersie CL, Naylor G, Phillips NA, Richter M, Rudner M, Sommers MS, Tremblay KL, Wingfield A. Hearing Impairment and Cognitive Energy: The Framework for Understanding Effortful Listening (FUEL). Ear Hear. 2016 Jul-Aug;37 Suppl 1:5S-27S. doi: 10.1097/AUD.0000000000000312.

  PMID: 27355771 BACKGROUND

• Zekveld AA, Kramer SE, Festen JM. Cognitive load during speech perception in noise: the influence of age, hearing loss, and cognition on the pupil response. Ear Hear. 2011 Jul-Aug;32(4):498-510. doi: 10.1097/AUD.0b013e31820512bb.

  PMID: 21233711 BACKGROUND

• Dawes P, Emsley R, Cruickshanks KJ, Moore DR, Fortnum H, Edmondson-Jones M, McCormack A, Munro KJ. Hearing loss and cognition: the role of hearing AIDS, social isolation and depression. PLoS One. 2015 Mar 11;10(3):e0119616. doi: 10.1371/journal.pone.0119616. eCollection 2015.

  PMID: 25760329 BACKGROUND

• Panza F, Solfrizzi V, Logroscino G. Age-related hearing impairment-a risk factor and frailty marker for dementia and AD. Nat Rev Neurol. 2015 Mar;11(3):166-75. doi: 10.1038/nrneurol.2015.12. Epub 2015 Feb 17.

  PMID: 25686757 BACKGROUND

• Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, Brayne C, Burns A, Cohen-Mansfield J, Cooper C, Costafreda SG, Dias A, Fox N, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Ogunniyi A, Orgeta V, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020 Aug 8;396(10248):413-446. doi: 10.1016/S0140-6736(20)30367-6. Epub 2020 Jul 30. No abstract available.

  PMID: 32738937 BACKGROUND

• Griffiths TD, Lad M, Kumar S, Holmes E, McMurray B, Maguire EA, Billig AJ, Sedley W. How Can Hearing Loss Cause Dementia? Neuron. 2020 Nov 11;108(3):401-412. doi: 10.1016/j.neuron.2020.08.003. Epub 2020 Aug 31.

  PMID: 32871106 BACKGROUND

• Feldman A, Patou F, Baumann M, Stockmarr A, Waldemar G, Maier AM, Vogel A. Listen Carefully protocol: an exploratory case-control study of the association between listening effort and cognitive function. BMJ Open. 2022 Mar 9;12(3):e051109. doi: 10.1136/bmjopen-2021-051109.

  PMID: 35264340 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Anja Maier, Ph.D.

  DTU - Technical University of Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Deputy Head of Division, Group Leader

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: October 19, 2020
• Study Start: August 8, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)