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AgingHnWNCT05418998

Cognitive Training to Improve Mobility in Middle-aged and Older Adults

A study testing Executive function (EF) training in people with Aging and Age Related Hearing Loss, run by Concordia University, Montreal at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The proposed study is designed to evaluate the effect of at-home executive function training on cognition and mobility in older adults with age-related hearing loss (ARHL), older adults with normal hearing, and middle-aged adults. Read more about this study

Who is it for?
Ages 45 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Aging, Age Related Hearing Loss
What is being tested?
Executive function (EF) training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteCanada
Study dates
30 Aug 2020to 15 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Proficient in English (learned before age 5), can ambulate ≥ 10 meters independently, absence of cognitive impairment (neuropsychological test results in the average range compared to age norms), normal or corrected-to-normal visual acuity (ETDRS), availability of a home computer or tablet with internet connection.

Who cannot join

  • Reported major depression, substance abuse or significant psychiatric disorder, uncorrected visual impairment, vestibular impairment, Parkinson's disease or other neurological disorder or sequelae, clinically significant musculoskeletal disorders, diseases affecting the ear, or damage to the ear (e.g., occupational noise), onset of hearing loss prior to adulthood.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Concordia University

    Montreal, Quebec, H3G 1M8

Other trials in Canada

About this study

Official title: Training Cognition to Improve Mobility and Listening in Older Adults with Hearing Loss: Moving from Lab to Life

The proposed study is designed to evaluate the effect of at-home executive function training on cognition and mobility in older adults with age-related hearing loss (ARHL), older adults with normal hearing, and middle-aged adults.

Being tested
Executive function (EF) training
Keywords
Cognitive training, Executive function, Aging, Dual-task walking, Near-infrared spectroscopy, Hearing loss, Middle age, Mobility
Medical subject headings
Presbycusis, Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Executive function (EF) trainingBehavioural

    EF training will involve at-home computer- or tablet based training to improve several EF processes, including divided attention, response inhibition, switching, and working memory updating. Training session duration = 30 min x 3 session/week.

Study groups in NCT05418998
Study groupRoleWhat they receive
Executive function (EF) trainingExperimental12 weeks of at-home EF training on a computer or iPad
Receives: Behavioral: Executive function (EF) training
Wait-list controlNo interventionThis will be a comparator arm with no cognitive training. Participants will be given access to the same training program following the conclusion of the study, but no further assessment is planned.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pre-training Change in auditory 2-back accuracy

    Auditory 2-back performance will be assessed under single- and dual-task conditions (i.e., while the participant is standing or simultaneously walking on a treadmill at a self-selected pace). The numbers for the task will be played through binaural speakers, and the decibel level will be individualized for each participant depending on hearing ability. Participants will be required to make a button response indicating whether the number they heard was the same or different from the number they heard two previously. Accuracy (percent correct) will be recorded. Half the participants will be given this assessment. See Outcome 5, Multi-talker, for other half.

    Measured: baseline

  2. Post-training Change in auditory 2-back accuracy

    Auditory 2-back performance will be assessed under single- and dual-task conditions (i.e., while the participant is standing or simultaneously walking on a treadmill at a self-selected pace). The numbers for the task will be played through binaural speakers, and the decibel level will be individualized for each participant depending on hearing ability. Participants will be required to make a button response indicating whether the number they heard was the same or different from the number they heard two previously. Accuracy (percent correct) will be recorded. Half the participants will be given this assessment. See Outcome 6, Multi-talker, for other half.

    Measured: after 12 weeks

  3. Pre-training Change in auditory 2-back reaction time

    Auditory 2-back performance will be assessed under single- and dual-task conditions (i.e., while the participant is standing or simultaneously walking on a treadmill at a self-selected pace). The numbers for the task will be played through binaural speakers, and the decibel level will be individualized for each participant depending on hearing ability. Participants will be required to make a button response indicating whether the number they heard was the same or different from the number they heard two previously. Reaction time (msec) will be recorded. Half the participants will be given this assessment. See Outcome 5, Multi-talker, for other half.

    Measured: baseline

  4. Post-training Change in auditory 2-back reaction time

    Auditory 2-back performance will be assessed under single- and dual-task conditions (i.e., while the participant is standing or simultaneously walking on a treadmill at a self-selected pace). The numbers for the task will be played through binaural speakers, and the decibel level will be individualized for each participant depending on hearing ability. Participants will be required to make a button response indicating whether the number they heard was the same or different from the number they heard two previously. Reaction time (msec) will be recorded. Half the participants will be given this assessment. See Outcome 6, Multi-talker, for other half.

    Measured: after 12 weeks

  5. Pre-training Multi-Talker word perception (accuracy)

    We will use the multi-talker spatial listening task for the other half of the participants, in which a presented text cue indicates which of three simultaneously presented, but spatially distributed spoken sentences to report. Traffic noise will be included to more closely simulate real- world conditions. The signal-to-noise ratio will be held constant across participants, with signal intensity set according to individual average hearing thresholds.

    Measured: baseline

  6. Post-training Multi-Talker word perception (accuracy)

    We will use the multi-talker spatial listening task for the other half of the participants, in which a presented text cue indicates which of three simultaneously presented, but spatially distributed spoken sentences to report. Traffic noise will be included to more closely simulate real- world conditions. The signal-to-noise ratio will be held constant across participants, with signal intensity set according to individual average hearing thresholds.

    Measured: after 12 weeks

  7. Pre-training Change in stride time (mean, standard deviation [SD] of stride time)

    Stride time will be assessed under single- and dual-task conditions (i.e., walking on a treadmill at a self-selected pace or while simultaneously completing the auditory 2-back task). The spatio-temporal characteristics of gait will be measured by foot pressure sensors worn on the base of the participants' shoes, with one sensor placed beneath the heel and the second sensor placed beneath the toe. The time between successive toe or heel strikes will be recorded (sec) and averaged across the trials. Those participants being assessed with Outcome 5 will perform the same walking task but in a simulated street-crossing environment.

    Measured: baseline

  8. Post-training Change in stride time (mean, standard deviation [SD] of stride time)

    Stride time will be assessed under single- and dual-task conditions (i.e., walking on a treadmill at a self-selected pace or while simultaneously completing the auditory 2-back task). The spatio-temporal characteristics of gait will be measured by foot pressure sensors worn on the base of the participants' shoes, with one sensor placed beneath the heel and the second sensor placed beneath the toe. The time between successive toe or heel strikes will be recorded (sec) and averaged across the trials. Those participants being assessed with Outcome 6 will perform the same walking task but in a simulated street-crossing environment.

    Measured: after 12 weeks

  9. Pre-training Change in stride time variability (mean, standard deviation [SD] of stride time)

    Stride time variability will be assessed under single- and dual-task conditions (i.e., walking on a treadmill at a self-selected pace or while simultaneously completing the auditory 2-back task). The spatio-temporal characteristics of gait will be measured by foot pressure sensors worn on the base of the participants' shoes, with one sensor placed beneath the heel and the second sensor placed beneath the toe. The time between successive toe or heel strikes will be recorded (sec) and the standard deviation will be taken to derive a measure of stride time variability. Those participants being assessed with Outcome 5 will perform the same walking task but in a simulated street-crossing environment.

    Measured: baseline

  10. Post-training Change in stride time variability (mean, standard deviation [SD] of stride time)

    Stride time variability will be assessed under single- and dual-task conditions (i.e., walking on a treadmill at a self-selected pace or while simultaneously completing the auditory 2-back task). The spatio-temporal characteristics of gait will be measured by foot pressure sensors worn on the base of the participants' shoes, with one sensor placed beneath the heel and the second sensor placed beneath the toe. The time between successive toe or heel strikes will be recorded (sec) and the standard deviation will be taken to derive a measure of stride time variability. Those participants being assessed with Outcome 6 will perform the same walking task but in a simulated street-crossing environment.

    Measured: after 12 weeks

Secondary outcomes (26)
  1. Pre-training Montreal Cognitive Assessment (MoCA)

    Neuropsychological test to evaluate global cognitive status. Scored on 30, a score of 26 or higher is used to identify Mild Cognitive Impairment (MCI) however a score of 23 or higher is used in this study as this cut-off has been shown to lower false positivity. (Nasreddine et al., 2005)

    Measured: baseline

  2. Post-training Montreal Cognitive Assessment (MoCA)

    Neuropsychological test to evaluate global cognitive status. Scored on 30, a score of 26 or higher is used to identify Mild Cognitive Impairment (MCI) however a score of 23 or higher is used in this study as this cut-off has been shown to lower false positivity. (Nasreddine et al., 2005)

    Measured: after 12 weeks

  3. Pre-training WAIS-IV Digit Symbol Coding

    Neuropsychological test to evaluate processing speed. Subtest of the Wechsler Adult Intelligence Scale IV (WAIS; Wechsler, 2008). Scored based on correct number of symbols completed in 120 seconds.

    Measured: baseline

  4. Post-training WAIS-IV Digit Symbol Coding

    Neuropsychological test to evaluate processing speed. Subtest of the Wechsler Adult Intelligence Scale IV (WAIS; Wechsler, 2008). Scored based on correct number of symbols completed in 120 seconds.

    Measured: after 12 weeks

  5. Pre-training Trail Making Test

    Neuropsychological test to evaluate processing speed and executive functioning (Reitan, 1992). In form A, participants use a pencil to connect circles on a page in ascending numerical order. In form B, participants connect circles, alternating between ascending number and letter series. Time to complete (s) is recorded per form. Difference between Forms B and A completion times provides an index of switching, updating, and is considered a measure of executive function.

    Measured: baseline

  6. Post-training Trail Making Test

    Neuropsychological test to evaluate processing speed and executive functioning (Reitan, 1992). In form A, participants use a pencil to connect circles on a page in ascending numerical order. In form B, participants connect circles, alternating between ascending number and letter series. Time to complete (s) is recorded per form. Difference between Forms B and A completion times provides an index of switching, updating, and is considered a measure of executive function.

    Measured: after 12 weeks

  7. Pre-training D-KEFS Stroop

    Delis-Kaplan Executive Function System (D-KEFS) Color-Word Interference Test (CWIT) is a neuropsychological test to evaluate processing speed and executive functioning (adapted from Delis, Kaplan, \& Kramer, 2001). A modification of the Stroop task (Stroop, 1935). In the CWIT, participants are asked to complete four conditions: colour naming, reading (both discontinued after 90 seconds), inhibition, and inhibition/switching (both discontinued after 180 seconds). Number correctly completed per condition.

    Measured: baseline

  8. Post-training D-KEFS Stroop

    Delis-Kaplan Executive Function System (D-KEFS) Color-Word Interference Test (CWIT) is a neuropsychological test to evaluate processing speed and executive functioning (adapted from Delis, Kaplan, \& Kramer, 2001). A modification of the Stroop task (Stroop, 1935). In the CWIT, participants are asked to complete four conditions: colour naming, reading (both discontinued after 90 seconds), inhibition, and inhibition/switching (both discontinued after 180 seconds). Number correctly completed per condition.

    Measured: after 12 weeks

  9. Pre-training Rey Auditory Verbal Learning Test

    Neuropsychological test to evaluate verbal memory (RAVLT; Rey, A. (1941). Scored by: adding up to correctly recalled words for each trial to obtain immediate recall total; how many correctly recalled words after the 30-minute interval to obtain their delayed recall total; divided delayed recall total by the total words correctly recalled on the fifth (last) trial of the initial administration and multiplied by 100 to obtain their percentage retention value.

    Measured: baseline

  10. Post-training Rey Auditory Verbal Learning Test

    Neuropsychological test to evaluate verbal memory (RAVLT; Rey, A. (1941). Scored by: adding up to correctly recalled words for each trial to obtain immediate recall total; how many correctly recalled words after the 30-minute interval to obtain their delayed recall total; divided delayed recall total by the total words correctly recalled on the fifth (last) trial of the initial administration and multiplied by 100 to obtain their percentage retention value.

    Measured: after 12 weeks

  11. Pre-training WAIS-IV Digit span

    Neuropsychological test to evaluate short-term memory. Subtest of the Wechsler Adult Intelligence Scale IV (WAIS; Wechsler, 2008). Scored based on highest span length correctly completed.

    Measured: baseline

  12. Post-training WAIS-IV Digit span

    Neuropsychological test to evaluate short-term memory. Subtest of the Wechsler Adult Intelligence Scale IV (WAIS; Wechsler, 2008). Scored based on highest span length correctly completed.

    Measured: after 12 weeks

  13. Pre-training Subjective listening self efficacy

    Listening self-efficacy questionnaire (LSEQ: Smith, Pichora-Fuller, Watts, \& La More, 2011, Int J Audiol). Asks questions about one's self-rated ability to understand conversation in a variety of contexts, without the use of hearing aids, self-rated self-efficacy (0-100%). Internal consistency (Chronbach's α) = .96 (Smith et al., 2011).

    Measured: baseline

  14. Post-training Subjective listening self efficacy

    Listening self-efficacy questionnaire (LSEQ: Smith, Pichora-Fuller, Watts, \& La More, 2011, Int J Audiol). Asks questions about one's self-rated ability to understand conversation in a variety of contexts, without the use of hearing aids. Internal consistency (Chronbach's α) = .96 (Smith et al., 2011).

    Measured: after 12 weeks

  15. Pre-training Subjective balance confidence

    ABC Balance Confidence Questionnaire (Powell \& Myers, 1995, J Geront: MedSci). Sixteen-item questionnaire concerning self-rated confidence (0-100%) balancing in different physical activities and contexts.

    Measured: baseline

  16. Post-training Subjective balance confidence

    ABC Balance Confidence Questionnaire (Powell \& Myers, 1995, J Geront: MedSci). Sixteen-item questionnaire concerning self-rated confidence (0-100%) balancing in different physical activities and contexts.

    Measured: after 12 weeks

  17. Pre-training Mobility functioning as assessed by the Mini BESTest

    The Mini BESTest is comprised of four sub-scales to evaluate balance performance, including an anticipatory sub-scale (e.g., sit-to-stand, toe rise), a reactive postural control subscale (measures compensatory stepping when one's centre of balance is displaced in the forward, backward, or lateral position), a sensory orientation subscale (e.g., eyes closed, foam mat), and a gait subscale (e.g., walking over an obstacle).

    Measured: baseline

  18. Post-training Mobility functioning as assessed by the Mini BESTest

    The Mini BESTest is comprised of four sub-scales to evaluate balance performance, including an anticipatory sub-scale (e.g., sit-to-stand, toe rise), a reactive postural control subscale (measures compensatory stepping when one's centre of balance is displaced in the forward, backward, or lateral position), a sensory orientation subscale (e.g., eyes closed, foam mat), and a gait subscale (e.g., walking over an obstacle).

    Measured: after 12 weeks

  19. Pre-training Functional neuroimaging (fNIRS)

    Portable functional near infrared spectroscopy (BRITE MKII) will be used to assess prefrontal cortex activity during the single- and dual-task walking conditions. Sixteen detectors will be placed strategically 2.8 cm away from the optodes, eight of them will be dorsal to the optodes, while the other eight will be ventral, so that each probe has four dorsal detectors and four ventral detectors. The two probes will be placed symmetrically over the lateral prefrontal cortex and the most anterior and most ventral pair of optode-detector of each probe will be placed on Fp1/Fp2. The probes were designed based on existing configurations. Of interest are relative changes in concentration of frontal oxy-hemoglobin (HbO2: measured at absorption peak of 850nm) and deoxy-hemoglobin (HbR: measured at absorption peak of 735nm) compared to the baseline rest data.

    Measured: baseline

  20. Post-training Functional neuroimaging (fNIRS)

    Portable functional near infrared spectroscopy (BRITE MKII) will be used to assess prefrontal cortex activity during the single- and dual-task walking conditions. Sixteen detectors will be placed strategically 2.8 cm away from the optodes, eight of them will be dorsal to the optodes, while the other eight will be ventral, so that each probe has four dorsal detectors and four ventral detectors. The two probes will be placed symmetrically over the lateral prefrontal cortex and the most anterior and most ventral pair of optode-detector of each probe will be placed on Fp1/Fp2. The probes were designed based on existing configurations. Of interest are relative changes in concentration of frontal oxy-hemoglobin (HbO2: measured at absorption peak of 850nm) and deoxy-hemoglobin (HbR: measured at absorption peak of 735nm) compared to the baseline rest data.

    Measured: after 12 weeks

  21. Pre-training Standing Balance (Path length)

    Postural measures will include spatial measures (centre of pressure path length; cm) in the anterior-posterior (front and back) and medial-lateral (side-to-side) orientations.

    Measured: baseline

  22. Pre-training Standing Balance (Velocity)

    Postural measures will include temporal measures (velocity; cm/s) in the anterior-posterior (front and back) and medial-lateral (side-to-side) orientations.

    Measured: baseline

  23. Pre-training Standing Balance (Variability)

    Postural measures will include variability measures (root means square, standard deviation) in the anterior-posterior (front and back) and medial-lateral (side-to-side) orientations.

    Measured: baseline

  24. Post-training Standing Balance (Path length)

    Postural measures will include spatial measures (centre of pressure path length; cm) in the anterior-posterior (front and back) and medial-lateral (side-to-side) orientations.

    Measured: after 12 weeks

  25. Post-training Standing Balance (Velocity)

    Postural measures will include temporal measures (velocity; cm/s) in the anterior-posterior (front and back) and medial-lateral (side-to-side) orientations.

    Measured: after 12 weeks

  26. Post-training Standing Balance (Variability)

    Postural measures will include variability measures (root means square, standard deviation) in the anterior-posterior (front and back) and medial-lateral (side-to-side) orientations.

    Measured: after 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2022
  2. Study start30 Aug 2020
  3. Primary completion15 Aug 2023
  4. Study completion15 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05418998
Sponsor's protocol ID
30011799
Acronym
HnW
Status last verified
Mar 2025
First submitted
26 May 2022
Last updated
14 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Mohanathas N, Montanari L, Downey R, Li KZH, Pichora-Fuller MK, Bherer L, Lussier M, Phillips N, Wittich W, St-Onge N, Gagne JP, Campos JL. Effects of executive function training on balance and auditory-cognitive dual-task performance in adults with and without hearing loss. PLoS One. 2026 Apr 29;21(4):e0331276. doi: 10.1371/journal.pone.0331276. eCollection 2026.

    PubMed 42054294
  • Downey R, Gagne N, Mohanathas N, Campos JL, Pichora-Fuller KM, Bherer L, Lussier M, Phillips NA, Wittich W, St-Onge N, Gagne JP, Li K. At-home computerized executive-function training to improve cognition and mobility in normal-hearing adults and older hearing aid users: a multi-centre, single-blinded randomized controlled trial. BMC Neurol. 2023 Oct 20;23(1):378. doi: 10.1186/s12883-023-03405-1.

    PubMed 37864139

Questions about this trial

What is this clinical trial studying?

A study testing Executive function (EF) training in people with Aging and Age Related Hearing Loss, run by Concordia University, Montreal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre-training Change in auditory 2-back accuracy (time frame: baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05418998, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.

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