Training Cognition to Improve Mobility and Listening in Older Adults with Hearing Loss: Moving from Lab to Life
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 63
- Locations
- 2
- Primary Endpoint
- Pre-training Change in stride time (mean, standard deviation [SD] of stride time)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Masking Description
The investigator will be blinded to group assignment.
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Pre-training Change in stride time (mean, standard deviation [SD] of stride time)
Time Frame: baseline
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.
Pre-training Change in auditory 2-back reaction time
Time Frame: baseline
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.
Post-training Multi-Talker word perception (accuracy)
Time Frame: after 12 weeks
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.
Post-training Change in stride time (mean, standard deviation [SD] of stride time)
Time Frame: after 12 weeks
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.
Pre-training Change in auditory 2-back accuracy
Time Frame: baseline
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.
Post-training Change in auditory 2-back reaction time
Time Frame: after 12 weeks
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.
Post-training Change in auditory 2-back accuracy
Time Frame: after 12 weeks
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.
Pre-training Multi-Talker word perception (accuracy)
Time Frame: baseline
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.
Pre-training Change in stride time variability (mean, standard deviation [SD] of stride time)
Time Frame: baseline
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.
Post-training Change in stride time variability (mean, standard deviation [SD] of stride time)
Time Frame: after 12 weeks
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.
Secondary Outcomes
- Post-training Montreal Cognitive Assessment (MoCA)(after 12 weeks)
- Post-training D-KEFS Stroop(after 12 weeks)
- Pre-training Rey Auditory Verbal Learning Test(baseline)
- Post-training WAIS-IV Digit span(after 12 weeks)
- Pre-training Subjective listening self efficacy(baseline)
- Post-training Subjective balance confidence(after 12 weeks)
- Pre-training Montreal Cognitive Assessment (MoCA)(baseline)
- Pre-training WAIS-IV Digit Symbol Coding(baseline)
- Post-training WAIS-IV Digit Symbol Coding(after 12 weeks)
- Pre-training Trail Making Test(baseline)
- Post-training Trail Making Test(after 12 weeks)
- Pre-training D-KEFS Stroop(baseline)
- Post-training Rey Auditory Verbal Learning Test(after 12 weeks)
- Pre-training Standing Balance (Velocity)(baseline)
- Pre-training WAIS-IV Digit span(baseline)
- Post-training Subjective listening self efficacy(after 12 weeks)
- Pre-training Subjective balance confidence(baseline)
- Pre-training Mobility functioning as assessed by the Mini BESTest(baseline)
- Post-training Mobility functioning as assessed by the Mini BESTest(after 12 weeks)
- Pre-training Standing Balance (Variability)(baseline)
- Post-training Standing Balance (Path length)(after 12 weeks)
- Post-training Standing Balance (Velocity)(after 12 weeks)
- Post-training Standing Balance (Variability)(after 12 weeks)
- Pre-training Functional neuroimaging (fNIRS)(baseline)
- Post-training Functional neuroimaging (fNIRS)(after 12 weeks)
- Pre-training Standing Balance (Path length)(baseline)
Investigators
Karen Li
Professor
Concordia University, Montreal