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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04593290
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Danish Dementia Research Centre
Information provided by (Responsible Party):
Anja Maier, Technical University of Denmark

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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment, Mild Hearing Loss Device: Oticon Opn S 1 miniRITE hearing aid Not Applicable

Detailed Description:

This is an exploratory proof-of-concept study and an exploratory intervention study with hearing aids in the context of listening effort. With a case (MCI) and control group (cognitively healthy), investigators will examine the associations between listening effort and cognitive function and assess the effect of hearing aid use on both listening effort and cognitive function test scores for those without hearing impairment. There is not sufficient literature to support a sample size calculation for this association study. Investigators will recruit approximately 50 participants. Half of these participants (n=25) will be individuals who have been diagnosed with MCI, according to the Winblad criteria (ICD10), with a Mini Mental State Examination (MMSE) score ≤ 26. The control group of participants (n=25) will be cognitively healthy individuals. All participants will undergo both listening effort testing, coupled with pupillometry and cognitive performance testing, based on a battery of pen-and-paper neuropsychological tests.

As investigators aim to measure cognitive effort exerted when listening and understanding speech in noise, is important that all study participants exhibit a normal sensitivity threshold within the ear canal. This will be assessed using Pure Tone Audiometry (PTA).

Assessment scores for cognitive function will be recorded in a clinical setting, and will be based on a battery of pen-and-paper neuropsychological cognitive tests. The Stroop Test, Trail Making Test (part A & B), Symbol Digit Modalities Test (SDMT), Verbal Fluency Tests (category: animals and lexical), Rey Complex Figure Test and Logical Memory Test (Part A) will be administered.

The objective measure of listening effort, pupil dilation, will be recorded as a measure of task performance accuracy and pupil dilation will be measured during a SWIR test, which is used to measure speech identification and recall in varying background noise. Prior to the SWIR test, participants undergo an adaptive Danish Hearing in Noise Test (HINT), comprising a list of equally intelligible sentences to be repeated in varying decibel (dB) levels of background noise to determine the individual's speech reception threshold (SRT) at 80% correct responses.

During the SWIR test, the participant is fitted with PupilLabs' eye-tracking system, an open source system consisting of clip-in eye tracking hardware to be placed in a Virtual Reality (VR) headset. To prevent floor and ceiling effects that are independent to baseline pupil size, the illumination within the VR display is individually adapted to the individual's midpoint prior to data collection between dim (~30 lux) and bright (~230 lux), with an average illuminance of 110 lux. A software suite allows the capture and post-processing of the data feed, including pupil diameter. For the purpose of this study, the PupilLabs software is controlled via a MATLAB interface.

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 second generation of the National Acoustic Laboratories (NAL) fitting protocol (NAL-NL2) and will increase gain seven steps on top of Real Ear Unaided Gain (REUG) from 750 Hz to 6 kHz.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Listen Carefully: An Exploratory Study of the Association Between Listening Effort and Cognitive Function
Actual Study Start Date : August 8, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

Arm Intervention/treatment
Experimental: Mild Cognitive Impairment (MCI)
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
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.

Active Comparator: Cognitively Healthy
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
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.




Primary Outcome Measures :
  1. Listening effort [ Time Frame: Baseline, pre-intervention ]
    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.

  2. The Stroop Color and Word test [ Time Frame: Baseline, pre-intervention ]

    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.


  3. Rey Complex Figure Test [ Time Frame: Baseline, pre-intervention ]

    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


  4. Symbol-Digit Modalities Test [ Time Frame: Baseline, pre-intervention ]

    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.


  5. Trail Making Test A and B [ Time Frame: Baseline, pre-intervention ]

    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.


  6. Verbal Fluency Test (category and lexical) [ Time Frame: Baseline, pre-intervention ]

    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.


  7. Logical Memory Test A [ Time Frame: Baseline, pre-intervention ]

    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.



Secondary Outcome Measures :
  1. Listening effort post-hearing aid use [ Time Frame: Post-intervention, after 6 weeks of intervention (hearing aid use) ]
    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.

  2. Logical Memory Test A post-hearing aid use [ Time Frame: Post-intervention, after 6 weeks of intervention (hearing aid use) ]

    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).

    A higher score corresponds to improved performance


  3. Verbal Fluency Test (category and lexical) post-hearing aid use [ Time Frame: Post-intervention, after 6 weeks of intervention (hearing aid use) ]

    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 corresponds to improved performance.


  4. Trail Making Test A and B - post-hearing aid use [ Time Frame: Post-intervention, after 6 weeks of intervention (hearing aid use) ]

    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.


  5. Symbol-Digit Modalities Test [ Time Frame: Post-intervention, after 6 weeks of intervention (hearing aid use) ]

    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.


  6. Rey Complex Figure Test [ Time Frame: Post-intervention, after 6 weeks of intervention (hearing aid use) ]

    Neuropsychological assessment where participants 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 corresponds to improved performance.


  7. The Stroop Color and Word test [ Time Frame: Post-intervention, after 6 weeks of intervention (hearing aid use) ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

MCI group

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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:

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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;
  • Abuses alcohol or drugs;
  • Is unable to comply with study procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04593290


Contacts
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Contact: Alix Feldman, Ph.D. fellow 004552654287 afeld@dtu.dk
Contact: Asmus Vogel, Ph.D. 004535456702 asmus.vogel.01@regionh.dk

Locations
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Denmark
Copenhagen Memory Clinic, Rigshospitalet Recruiting
Copenhagen, Region H, Denmark, 2100
Contact: Gunhild Waldemar, M.D.    0045 35 45 25 80    gunhild.waldemar.01@regionh.dk   
Contact: Asmus Vogel, Ph.D.    0045 35 45 67 02    asmus.vogel.01@regionh.dk   
Sponsors and Collaborators
Technical University of Denmark
Danish Dementia Research Centre
Investigators
Layout table for investigator information
Principal Investigator: Anja Maier, Ph.D. DTU - Technical University of Denmark
Publications:

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Responsible Party: Anja Maier, Professor, Deputy Head of Division, Group Leader, Technical University of Denmark
ClinicalTrials.gov Identifier: NCT04593290    
Other Study ID Numbers: 19042404
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases