Bilateral Hearing Loss, Healthy Aging
Conditions
Brief summary
The specific aims of the research study are: 1. Compare single-task gait parameters between individuals with hearing loss (HL) and age and education matched controls with normal hearing \[normal vs moderate-profound hearing loss (N=23 for each group)\]. For that we will compare the primary outcome measure, gait speed, between the groups while participants are walking at a comfortable speed for 1 minute. 2. Compare cognitive function between individuals with HL and age and education matched controls. For that we will compare the Neurocognitive Index, derived from a cognitive assessment between groups. 3. Compare the effect of a cognitive task while walking on gait parameters between people with HL and age education matched controls with normal hearing. For that we will compare the primary outcome measure, gait speed, between groups while participants are walking at a comfortable speed and counting backwards \[serial subtraction of 3\] for 1 minute. 4. Explore whether cognitive performance (i.e., the Neurocognitive Index) is correlated with Dual task cost (DTC), a deterioration of gait speed while walking and performing concurrent cognitive task \[serial subtraction of 3\]. The formula to calculate this is the following: DTC = 100 X \[(DT - single task)/ single task\].
Detailed description
Procedure and Data Collection: Participants will be tested at the NYU Physical Therapy department (380 2nd Ave 3rd and 4th floors). Data will be collected by the main researcher who proposes this research work and/or two other lab researchers who are trained to conduct the full protocol. Testing will take between 1.5 to 2 hours and will always start with the cognitive assessment in order to make sure participants will perform at their best and will not be fatigued. All participants will sign an informed consent form. Participates with HL will be tested without hearing aids since recent studies suggest a possible improvement in balance as well as cognition with amplification. Participates will take off their hearing aid at the beginning of testing. Screening Examination and Descriptive Measures of participants: The participants will undergo a sensory systems screen including: Early Treatment Diabetic Retinopathy Study (ETDRS) chart confirming normal vision and a 5.07 monofilament screen confirming normal protective sensation at the bottom of their feet. The screening for the vestibular system will include the Dizziness Handicap Inventory (DHI) questionnaire. Screening of the auditory system will be done in participants with HL (as part of their standard care) and for healthy controls who are 60 years of age or older. Participants will also complete the following questionnaires: a demographics and anthropometrics questionnaire, and Activities-Specific Balance Confidence (ABC) to assess balance confidence. To assess the history of falls questions about past falls will be asked. The MoCA will be administered for people with normal hearing, and the HI-MoCA for people with HL in order to assess mild cognitive decline. For people with HL, the Speech, Spatial and Qualities of Hearing Scale (SSQ12), a test assessing function and interference in hearing in daily living, will be conducted. To assess balance and mobility two tests will be conducted: the modified Clinical Test of Sensory Interaction on Balance (mCTSIB) and Time Up and Go Test (TUG). First participants will wear the APDM inertial motion sensors on both feet and waist and will perform the mCTSIB. They will stand with their hands at their sides, feet together and will perform the following sensory conditions for 30 sec: (1) Stand on a firm surface with eyes open, (2) Stand on a firm surface with eyes closed, (3) Stand on a foam with eyes open, and (4) Stand on a foam with eyes closed. Secondly, participants will perform the TUG twice. The best performance in each condition out of the 2 performances will be recorded. Cognitive Assessment: Participants will complete a computerized cognitive battery (CNS vital sign; CNSVS) that will include verbal memory, visual memory, Stroop test, shifting attention and 4-part continuous performance (sustained attention and working memory). Moreover, performance on the single cognitive task (serial subtraction in jumps of 3; measuring working memory and executive function) will also be evaluated while sitting (cognitive single task). The numbers will be recorded for offline processing and the outcome will be the number of correct numbers. These tests do not require the ability to hear in order to pass successfully. Also, there is a need for investigation of cognitive domains such as attention, memory, executive function, and cognitive flexibility in people with HL. Gait Assessment: The average speed of gait and spatiotemporal gait parameters would be calculated by the APDM, inertial motion units. Participants will walk in their normal speed for 1 minute along a corridor, back and forth, with or without performing a cognitive task (single or DT). The DT condition will include serial subtraction (counting backwards out loud) in jumps of 3 from a random three-digit number. Randomization of numbers will be done using the excel function generating random numbers (Excel RAND function). The numbers will be recorded for offline processing and the outcome will be the number of correct numbers. Each condition will be performed once, and all conditions will be randomized.
Interventions
OTHERGait assessment
The average speed of gait and spatiotemporal gait parameters would be calculated by the APDM, inertial motion units. Participants will walk in their normal speed for 1 minute along a corridor, back and forth, with or without performing a cognitive task (single or DT). The DT condition will include serial subtraction (counting backwards out loud) in jumps of 3 from a random three-digit number. Randomization of numbers will be done using the excel function generating random numbers (Excel RAND function). The numbers will be recorded for offline processing and the outcome will be the number of correct numbers. Each condition will be performed once, and all conditions will be randomized.
OTHERCognitive assessment
Participants will complete a computerized cognitive battery (CNS vital sign; CNSVS)that will include verbal memory, visual memory, Stroop test, shifting attention and 4-part continuous performance (sustained attention and working memory). Moreover, performance on the single cognitive task (serial subtraction in jumps of 3; measuring working memory and executive function) will also be evaluated while sitting (cognitive single task). The numbers will be recorded for offline processing and the outcome will be the number of correct numbers. These tests do not require the ability to hear in order to pass successfully. Also, there is a need for investigation of cognitive domains such as attention, memory, executive function, and cognitive flexibility in people with HL.
Sponsors
Icahn School of Medicine at Mount Sinai
New York University
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical moderate which is defined as a PTA between 41-55dB HL (0.5-4 kHz) in the better ear. * Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical moderately-severe which is defined as a PTA between 56-70dB HL (0.5-4 kHz) in the better ear. * Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical severe which is defined as a PTA between 71-90dB HL (0.5-4 kHz) in the better ear. * Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical profound which is defined as a PTA above 90+dB HL (0.5-4 kHz) in the better ear. * No asymmetry of HL which is defined as a difference in PTA that is greater than 15 dB between ears or a difference greater than/equal to 20 dB at two contiguous frequencies or greater than/equal to 10 dB at three contiguous frequencies between ears. * Adults aged 40 and older with normal hearing which is defined as a PTA below 25dB (0.5-4 kHz) bilaterally. * Subjects above 65 years of age, with symmetric ARHL in the high frequencies (\>3K), with unaided PTA \< 40 dB (0.5-4KHz) will be included in the control group as well.
Exclusion criteria
* A medical diagnosis of peripheral neuropathy. * Lack of protective sensation based on the Semmes-Weinstein 5.07 Monofilament Test. * Visual impairment above 20/63 (NYS Department of Motor Vehicle cutoff for driving) on the Early Treatment Diabetic Retinopathy Study (ETDRS) Acuity Test that cannot be corrected with lenses. * Active complaint of dizziness * Conductive HL or air bone gap * A recent onset of a sudden HL * Pregnancy * Any neurological condition interfering with balance or walking (e.g. multiple sclerosis, Parkinson's disease, stroke) * Acute musculoskeletal pain at time of testing * Currently seeking medical care for another orthopaedic condition or vestibular rehabilitation * Take medications that might influence gait or balance (e.g., methylphenidate); * Inability to read an informed consent form in English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait Speed (Single Task) Over 1-minute Walk | 60 seconds of a walk. | The gait speed while walking for 1 min will be compared between groups. Normal gait speed will be considered 1.2-1.3 m/sec. |
| The Neurocognitive Index | 30 minutes of assessment. | The Neurocognitive Index is the average of standardised scores obtained out of six cognitive sub-domains: Composite Memory, Reaction Time, Cognitive Flexibility, Executive Function, Working Memory and Sustained Attention, representing a form of a global score of the overall neurocognitive status of the subject. The range of the six cognitive sub-domains standardised scores and of the Neurocognitive Index is: below 70 which counts as very low score and above 110 which counts as an above averge score. Higher scores are better. Standard Scores are normalized from raw scores and present an age matched score relative to other people in a normative sample. Standardized scores have a mean of 100 and a standard deviation is 15. The schema where the mean is 100 and the standard deviation is 15 is similar to the presentation of IQ scores where the mean for normal is 100. |
| Gait Speed (Dual Task {DT}) Over 1-minute Walk | 60 seconds of a walk. | To test allocation of attention during walking using DT paradigm the DT gait speed while walking for 1 min and performing a cognitive task which was serial subtraction (counting backwards out loud) in jumps of 3 from a random three-digit number was compared between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single and Dual Task Stride Length | 60 seconds of a walk. | Stride length while walking for one minute (single task) and while walking and counting backwards subtracting 3 from a 3 digit number (Dual task) was measures as the distance between two successive placements of the same foot. It consists of two step lengths, left and right.It was measured in meters (m). |
| Single and Dual Task Stride Time Variability | 60 second of walking | Variability of stride time is the stride-to-stride fluctuations in walking or gait unsteadiness; a measure of inconsistency and arrhythmicity of stepping. Stride Time Variability while walking for one minute (single task) and while walking and counting backwards subtracting 3 from a 3 digit number (Dual task) was measures as the coefficient of variation (CV) which is a measure of the relative variability. It was calculated as the ratio of the standard deviation to the mean. The formula to calculate that is the following: CV = 100 X (standard deviation/mean). |
| Single and Dual Task Stride Time | 60 second of a walk | Stride time while walking for one minute (single task) and while walking and counting backwards subtracting 3 from a 3 digit number (Dual task) was measures as the time from initial contact to the next initial contact of the same foot. It was measured in seconds. |
| Single and Dual Task Stride Length Variability | 60 second of walking | Variability of stride length is the stride-to-stride fluctuations in walking or gait unsteadiness; a measure of inconsistency and arrhythmicity of stepping. Stride Length Variability while walking for one minute (single task) and while walking and counting backwards subtracting 3 from a 3 digit number (Dual task) was measures as the coefficient of variation (CV) which is a measure of the relative variability. It was calculated as the ratio of the standard deviation to the mean. The formula to calculate that is the following: CV = 100 X (standard deviation/mean). |
Countries
United States
Participant flow
Recruitment details
Control participants were recruited through the clinicaltrials.org website, the New York University community and via word of mouth. People with a clinical diagnosis of bilateral symmetrical mild, moderate, moderately-severe, severe, or profound sensorineural BHL for three months or longer were recruited from the New York Ear & Eye Institute of Mount Sinai (NYEEIMS) and the clinicaltrials.org website.
Participants by arm
| Arm | Count |
|---|---|
| Normal Hearing Normal hearing: according to the WHO classification43 was defined as a PTA below 25dB (0.5-4 kHz) bilaterally. | 28 |
| Mild BHL Mild BHL: according to the WHO classification43 was defined as a PTA between 25-40dB BHL(0.5-4 kHz) in the better ear. | 16 |
| >Moderate BHL Moderate BHL: according to the WHO classification43 was defined as a PTA between 41-55dB BHL(0.5-4 kHz) in the better ear.
Moderately-severe BHL: according to the WHO classification43 was defined as a PTA between 56-70 BHL(0.5-4 kHz) in the better ear.
Severe BHL: according to the WHO classification43 was defined as a PTA between 71-90dB BHL(0.5-4 kHz) in the better ear.
Profound BHL: according to the WHO classification43 was defined as a PTA between 91+ dB BHL(0.5-4 kHz) in the better ear. | 15 |
| Total | 59 |
Baseline characteristics
| Characteristic | Total | Normal Hearing | Mild BHL | >Moderate BHL |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 35 Participants | 11 Participants | 14 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 17 Participants | 2 Participants | 5 Participants |
| Age, Continuous | 66.36 years STANDARD_DEVIATION 13.42 | 59.14 years STANDARD_DEVIATION 11.96 | 74.69 years STANDARD_DEVIATION 8.67 | 70.93 years STANDARD_DEVIATION 13.59 |
| Falls over the past year | 13 Falls | 5 Falls | 5 Falls | 3 Falls |
| Race/Ethnicity, Customized Alaska Native | 1 participants | 0 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Asian American | 4 participants | 2 participants | 2 participants | 0 participants |
| Race/Ethnicity, Customized Asian / Pacific Islander | 1 participants | 0 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Black or African American | 5 participants | 3 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Caucasian | 43 participants | 20 participants | 11 participants | 12 participants |
| Race/Ethnicity, Customized Others | 3 participants | 1 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Spanish / Hispanic | 2 participants | 2 participants | 0 participants | 0 participants |
| Region of Enrollment Israel | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Region of Enrollment United States | 57 Participants | 28 Participants | 14 Participants | 15 Participants |
| Sex: Female, Male Female | 31 Participants | 13 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Male | 28 Participants | 15 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 0 / 28 | 0 / 16 | 0 / 15 |
| serious Total, serious adverse events | 0 / 28 | 0 / 16 | 0 / 15 |
Outcome results
Primary
Gait Speed (Dual Task {DT}) Over 1-minute Walk
To test allocation of attention during walking using DT paradigm the DT gait speed while walking for 1 min and performing a cognitive task which was serial subtraction (counting backwards out loud) in jumps of 3 from a random three-digit number was compared between groups.
Time frame: 60 seconds of a walk.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Participants With Normal Hearing. | Gait Speed (Dual Task {DT}) Over 1-minute Walk | 0.95 m/sec | Standard Deviation 0.2 |
| Mild Bilateral Symmetrical Hearing Loss | Gait Speed (Dual Task {DT}) Over 1-minute Walk | 0.84 m/sec | Standard Deviation 0.19 |
| >Moderate Bilateral Symmetrical Hearing Loss | Gait Speed (Dual Task {DT}) Over 1-minute Walk | 0.90 m/sec | Standard Deviation 0.1 |
p-value: <0.05Kruskal-Wallis
Primary
Gait Speed (Single Task) Over 1-minute Walk
The gait speed while walking for 1 min will be compared between groups. Normal gait speed will be considered 1.2-1.3 m/sec.
Time frame: 60 seconds of a walk.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Participants With Normal Hearing. | Gait Speed (Single Task) Over 1-minute Walk | 1.14 m/sec | Standard Deviation 0.15 |
| Mild Bilateral Symmetrical Hearing Loss | Gait Speed (Single Task) Over 1-minute Walk | 1.02 m/sec | Standard Deviation 0.21 |
| >Moderate Bilateral Symmetrical Hearing Loss | Gait Speed (Single Task) Over 1-minute Walk | 1.1 m/sec | Standard Deviation 0.1 |
p-value: <0.05Kruskal-Wallis
Primary
The Neurocognitive Index
The Neurocognitive Index is the average of standardised scores obtained out of six cognitive sub-domains: Composite Memory, Reaction Time, Cognitive Flexibility, Executive Function, Working Memory and Sustained Attention, representing a form of a global score of the overall neurocognitive status of the subject. The range of the six cognitive sub-domains standardised scores and of the Neurocognitive Index is: below 70 which counts as very low score and above 110 which counts as an above averge score. Higher scores are better. Standard Scores are normalized from raw scores and present an age matched score relative to other people in a normative sample. Standardized scores have a mean of 100 and a standard deviation is 15. The schema where the mean is 100 and the standard deviation is 15 is similar to the presentation of IQ scores where the mean for normal is 100.
Time frame: 30 minutes of assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Participants With Normal Hearing. | The Neurocognitive Index | 105.45 score on a scale | Standard Deviation 7.62 |
| Mild Bilateral Symmetrical Hearing Loss | The Neurocognitive Index | 108.15 score on a scale | Standard Deviation 5.7 |
| >Moderate Bilateral Symmetrical Hearing Loss | The Neurocognitive Index | 107.05 score on a scale | Standard Deviation 5.52 |
p-value: <0.05ANOVA
Secondary
Single and Dual Task Stride Length
Stride length while walking for one minute (single task) and while walking and counting backwards subtracting 3 from a 3 digit number (Dual task) was measures as the distance between two successive placements of the same foot. It consists of two step lengths, left and right.It was measured in meters (m).
Time frame: 60 seconds of a walk.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Participants With Normal Hearing. | Single and Dual Task Stride Length | Single Task stride length | 1.26 meter | Standard Deviation 0.13 |
| Control Participants With Normal Hearing. | Single and Dual Task Stride Length | Dual Task stride length | 1.15 meter | Standard Deviation 0.17 |
| Mild Bilateral Symmetrical Hearing Loss | Single and Dual Task Stride Length | Dual Task stride length | 1.02 meter | Standard Deviation 0.16 |
| Mild Bilateral Symmetrical Hearing Loss | Single and Dual Task Stride Length | Single Task stride length | 1.14 meter | Standard Deviation 0.17 |
| >Moderate Bilateral Symmetrical Hearing Loss | Single and Dual Task Stride Length | Single Task stride length | 1.20 meter | Standard Deviation 0.12 |
| >Moderate Bilateral Symmetrical Hearing Loss | Single and Dual Task Stride Length | Dual Task stride length | 1.09 meter | Standard Deviation 0.13 |
p-value: <0.05ANOVA
Secondary
Single and Dual Task Stride Length Variability
Variability of stride length is the stride-to-stride fluctuations in walking or gait unsteadiness; a measure of inconsistency and arrhythmicity of stepping. Stride Length Variability while walking for one minute (single task) and while walking and counting backwards subtracting 3 from a 3 digit number (Dual task) was measures as the coefficient of variation (CV) which is a measure of the relative variability. It was calculated as the ratio of the standard deviation to the mean. The formula to calculate that is the following: CV = 100 X (standard deviation/mean).
Time frame: 60 second of walking
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Participants With Normal Hearing. | Single and Dual Task Stride Length Variability | Single Task Stride Length Variability | 3.24 percent | Standard Deviation 1.09 |
| Control Participants With Normal Hearing. | Single and Dual Task Stride Length Variability | Dual Task Stride Length Variability | 3.94 percent | Standard Deviation 1.27 |
| Mild Bilateral Symmetrical Hearing Loss | Single and Dual Task Stride Length Variability | Single Task Stride Length Variability | 3.60 percent | Standard Deviation 1.23 |
| Mild Bilateral Symmetrical Hearing Loss | Single and Dual Task Stride Length Variability | Dual Task Stride Length Variability | 4.96 percent | Standard Deviation 1.62 |
| >Moderate Bilateral Symmetrical Hearing Loss | Single and Dual Task Stride Length Variability | Single Task Stride Length Variability | 3.79 percent | Standard Deviation 0.84 |
| >Moderate Bilateral Symmetrical Hearing Loss | Single and Dual Task Stride Length Variability | Dual Task Stride Length Variability | 3.89 percent | Standard Deviation 0.95 |
p-value: 0.05ANOVA
Secondary
Single and Dual Task Stride Time
Stride time while walking for one minute (single task) and while walking and counting backwards subtracting 3 from a 3 digit number (Dual task) was measures as the time from initial contact to the next initial contact of the same foot. It was measured in seconds.
Time frame: 60 second of a walk
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Participants With Normal Hearing. | Single and Dual Task Stride Time | Dual Task Stride time | 1.23 seconds | Standard Deviation 0.15 |
| Control Participants With Normal Hearing. | Single and Dual Task Stride Time | Single Task Stride time | 1.10 seconds | Standard Deviation 0.1 |
| Mild Bilateral Symmetrical Hearing Loss | Single and Dual Task Stride Time | Single Task Stride time | 1.14 seconds | Standard Deviation 0.1 |
| Mild Bilateral Symmetrical Hearing Loss | Single and Dual Task Stride Time | Dual Task Stride time | 1.24 seconds | Standard Deviation 0.13 |
| >Moderate Bilateral Symmetrical Hearing Loss | Single and Dual Task Stride Time | Single Task Stride time | 1.09 seconds | Standard Deviation 0.06 |
| >Moderate Bilateral Symmetrical Hearing Loss | Single and Dual Task Stride Time | Dual Task Stride time | 1.21 seconds | Standard Deviation 0.12 |
p-value: 0.05ANOVA
Secondary
Single and Dual Task Stride Time Variability
Variability of stride time is the stride-to-stride fluctuations in walking or gait unsteadiness; a measure of inconsistency and arrhythmicity of stepping. Stride Time Variability while walking for one minute (single task) and while walking and counting backwards subtracting 3 from a 3 digit number (Dual task) was measures as the coefficient of variation (CV) which is a measure of the relative variability. It was calculated as the ratio of the standard deviation to the mean. The formula to calculate that is the following: CV = 100 X (standard deviation/mean).
Time frame: 60 second of walking
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Participants With Normal Hearing. | Single and Dual Task Stride Time Variability | Single Task Stride Time Variability | 2.07 percent | Standard Deviation 0.56 |
| Control Participants With Normal Hearing. | Single and Dual Task Stride Time Variability | Dual Task Stride Time Variability | 3.34 percent | Standard Deviation 1.17 |
| Mild Bilateral Symmetrical Hearing Loss | Single and Dual Task Stride Time Variability | Single Task Stride Time Variability | 2.37 percent | Standard Deviation 0.71 |
| Mild Bilateral Symmetrical Hearing Loss | Single and Dual Task Stride Time Variability | Dual Task Stride Time Variability | 3.59 percent | Standard Deviation 0.12 |
| >Moderate Bilateral Symmetrical Hearing Loss | Single and Dual Task Stride Time Variability | Single Task Stride Time Variability | 2.31 percent | Standard Deviation 0.62 |
| >Moderate Bilateral Symmetrical Hearing Loss | Single and Dual Task Stride Time Variability | Dual Task Stride Time Variability | 3.60 percent | Standard Deviation 1.33 |
p-value: 0.05ANOVA