Trial Outcomes & Findings for Dual-Task Cost in Bilateral Hearing Loss (NCT NCT05540535)
NCT ID: NCT05540535
Last Updated: 2025-01-13
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
67 participants
Primary outcome timeframe
60 seconds of a walk.
Results posted on
2025-01-13
Participant Flow
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.
Participant milestones
| Measure |
Control Participants With Normal Hearing.
Normal hearing will be defined as a PTA below 25dB (0.5-4 kHz) bilaterally.
|
Mild Bilateral Symmetrical Hearing Loss
Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical moderate, moderately-severe, severe, or profound sensorineural HL in the past three month and on. Mild hearing will be defined as a PTA between 26-40dB HL (0.5-4 kHz) in the better ear.
|
>Moderate Bilateral Symmetrical Hearing Loss
Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical moderate, moderately-severe, severe, or profound sensorineural HL in the past three month and on. Moderate hearing will be defined as a PTA between 41-55dB HL (0.5-4 kHz) in the better ear, moderately-severe hearing will be defined as a PTA between 56-70dB HL (0.5-4 kHz) in the better ear, severe HL will be defined as a PTA between 71-90dB HL (0.5-4 kHz) in the better ear and profound HL will be defined as a PTA above 90+dB HL (0.5-4 kHz) in the better ear. Asymmetry of HL will be defined as a difference in PTA that is greater than 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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
19
|
18
|
|
Overall Study
COMPLETED
|
28
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dual-Task Cost in Bilateral Hearing Loss
Baseline characteristics by cohort
| Measure |
Normal Hearing
n=28 Participants
Normal hearing: according to the WHO classification43 was defined as a PTA below 25dB (0.5-4 kHz) bilaterally.
|
Mild BHL
n=16 Participants
Mild BHL: according to the WHO classification43 was defined as a PTA between 25-40dB BHL(0.5-4 kHz) in the better ear.
|
>Moderate BHL
n=15 Participants
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.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Age, Continuous
|
59.14 years
STANDARD_DEVIATION 11.96 • n=5 Participants
|
74.69 years
STANDARD_DEVIATION 8.67 • n=7 Participants
|
70.93 years
STANDARD_DEVIATION 13.59 • n=5 Participants
|
66.36 years
STANDARD_DEVIATION 13.42 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
20 participants
n=5 Participants
|
11 participants
n=7 Participants
|
12 participants
n=5 Participants
|
43 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Spanish / Hispanic
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian American
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian / Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Alaska Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Others
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Falls over the past year
|
5 Falls
n=5 Participants
|
5 Falls
n=7 Participants
|
3 Falls
n=5 Participants
|
13 Falls
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Participants With Normal Hearing.
n=28 Participants
Adults aged 40 and older with normal hearing will be defined as a PTA below 25dB (0.5-4 kHz) bilaterally.
|
Mild Bilateral Symmetrical Hearing Loss
n=16 Participants
Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical Mild HL in the past three month and on.
Mild hearing will be defined as a PTA between 26-40dB HL (0.5-4 kHz) in the better ear.
|
>Moderate Bilateral Symmetrical Hearing Loss
n=15 Participants
Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical moderate, moderately-severe, severe, or profound sensorineural HL in the past three month and on.
Moderate hearing will be defined as a PTA between 41-55dB HL (0.5-4 kHz) in the better ear, moderately-severe hearing will be defined as a PTA between 56-70dB HL (0.5-4 kHz) in the better ear, severe HL will be defined as a PTA between 71-90dB HL (0.5-4 kHz) in the better ear and profound HL will be defined as a PTA above 90+dB HL (0.5-4 kHz) in the better ear. Asymmetry of HL will be defined as a difference in PTA that is greater than 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.
|
|---|---|---|---|
|
Gait Speed (Single Task) Over 1-minute Walk
|
1.14 m/sec
Standard Deviation 0.15
|
1.02 m/sec
Standard Deviation 0.21
|
1.1 m/sec
Standard Deviation 0.10
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Participants With Normal Hearing.
n=26 Participants
Adults aged 40 and older with normal hearing will be defined as a PTA below 25dB (0.5-4 kHz) bilaterally.
|
Mild Bilateral Symmetrical Hearing Loss
n=11 Participants
Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical Mild HL in the past three month and on.
Mild hearing will be defined as a PTA between 26-40dB HL (0.5-4 kHz) in the better ear.
|
>Moderate Bilateral Symmetrical Hearing Loss
n=13 Participants
Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical moderate, moderately-severe, severe, or profound sensorineural HL in the past three month and on.
Moderate hearing will be defined as a PTA between 41-55dB HL (0.5-4 kHz) in the better ear, moderately-severe hearing will be defined as a PTA between 56-70dB HL (0.5-4 kHz) in the better ear, severe HL will be defined as a PTA between 71-90dB HL (0.5-4 kHz) in the better ear and profound HL will be defined as a PTA above 90+dB HL (0.5-4 kHz) in the better ear. Asymmetry of HL will be defined as a difference in PTA that is greater than 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.
|
|---|---|---|---|
|
The Neurocognitive Index
|
105.45 score on a scale
Standard Deviation 7.62
|
108.15 score on a scale
Standard Deviation 5.70
|
107.05 score on a scale
Standard Deviation 5.52
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Participants With Normal Hearing.
n=28 Participants
Adults aged 40 and older with normal hearing will be defined as a PTA below 25dB (0.5-4 kHz) bilaterally.
|
Mild Bilateral Symmetrical Hearing Loss
n=16 Participants
Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical Mild HL in the past three month and on.
Mild hearing will be defined as a PTA between 26-40dB HL (0.5-4 kHz) in the better ear.
|
>Moderate Bilateral Symmetrical Hearing Loss
n=14 Participants
Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical moderate, moderately-severe, severe, or profound sensorineural HL in the past three month and on.
Moderate hearing will be defined as a PTA between 41-55dB HL (0.5-4 kHz) in the better ear, moderately-severe hearing will be defined as a PTA between 56-70dB HL (0.5-4 kHz) in the better ear, severe HL will be defined as a PTA between 71-90dB HL (0.5-4 kHz) in the better ear and profound HL will be defined as a PTA above 90+dB HL (0.5-4 kHz) in the better ear. Asymmetry of HL will be defined as a difference in PTA that is greater than 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.
|
|---|---|---|---|
|
Gait Speed (Dual Task {DT}) Over 1-minute Walk
|
0.95 m/sec
Standard Deviation 0.20
|
0.84 m/sec
Standard Deviation 0.19
|
0.90 m/sec
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Control Participants With Normal Hearing.
n=28 Participants
Adults aged 40 and older with normal hearing will be defined as a PTA below 25dB (0.5-4 kHz) bilaterally.
|
Mild Bilateral Symmetrical Hearing Loss
n=16 Participants
Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical Mild HL in the past three month and on.
Mild hearing will be defined as a PTA between 26-40dB HL (0.5-4 kHz) in the better ear.
|
>Moderate Bilateral Symmetrical Hearing Loss
n=14 Participants
Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical moderate, moderately-severe, severe, or profound sensorineural HL in the past three month and on.
Moderate hearing will be defined as a PTA between 41-55dB HL (0.5-4 kHz) in the better ear, moderately-severe hearing will be defined as a PTA between 56-70dB HL (0.5-4 kHz) in the better ear, severe HL will be defined as a PTA between 71-90dB HL (0.5-4 kHz) in the better ear and profound HL will be defined as a PTA above 90+dB HL (0.5-4 kHz) in the better ear. Asymmetry of HL will be defined as a difference in PTA that is greater than 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.
|
|---|---|---|---|
|
Single and Dual Task Stride Length
Single Task stride length
|
1.26 meter
Standard Deviation 0.13
|
1.14 meter
Standard Deviation 0.17
|
1.20 meter
Standard Deviation 0.12
|
|
Single and Dual Task Stride Length
Dual Task stride length
|
1.15 meter
Standard Deviation 0.17
|
1.02 meter
Standard Deviation 0.16
|
1.09 meter
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: 60 second of a walkStride 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.
Outcome measures
| Measure |
Control Participants With Normal Hearing.
n=28 Participants
Adults aged 40 and older with normal hearing will be defined as a PTA below 25dB (0.5-4 kHz) bilaterally.
|
Mild Bilateral Symmetrical Hearing Loss
n=16 Participants
Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical Mild HL in the past three month and on.
Mild hearing will be defined as a PTA between 26-40dB HL (0.5-4 kHz) in the better ear.
|
>Moderate Bilateral Symmetrical Hearing Loss
n=14 Participants
Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical moderate, moderately-severe, severe, or profound sensorineural HL in the past three month and on.
Moderate hearing will be defined as a PTA between 41-55dB HL (0.5-4 kHz) in the better ear, moderately-severe hearing will be defined as a PTA between 56-70dB HL (0.5-4 kHz) in the better ear, severe HL will be defined as a PTA between 71-90dB HL (0.5-4 kHz) in the better ear and profound HL will be defined as a PTA above 90+dB HL (0.5-4 kHz) in the better ear. Asymmetry of HL will be defined as a difference in PTA that is greater than 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.
|
|---|---|---|---|
|
Single and Dual Task Stride Time
Single Task Stride time
|
1.10 seconds
Standard Deviation 0.10
|
1.14 seconds
Standard Deviation 0.10
|
1.09 seconds
Standard Deviation 0.06
|
|
Single and Dual Task Stride Time
Dual Task Stride time
|
1.23 seconds
Standard Deviation 0.15
|
1.24 seconds
Standard Deviation 0.13
|
1.21 seconds
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: 60 second of walkingVariability 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).
Outcome measures
| Measure |
Control Participants With Normal Hearing.
n=28 Participants
Adults aged 40 and older with normal hearing will be defined as a PTA below 25dB (0.5-4 kHz) bilaterally.
|
Mild Bilateral Symmetrical Hearing Loss
n=16 Participants
Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical Mild HL in the past three month and on.
Mild hearing will be defined as a PTA between 26-40dB HL (0.5-4 kHz) in the better ear.
|
>Moderate Bilateral Symmetrical Hearing Loss
n=14 Participants
Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical moderate, moderately-severe, severe, or profound sensorineural HL in the past three month and on.
Moderate hearing will be defined as a PTA between 41-55dB HL (0.5-4 kHz) in the better ear, moderately-severe hearing will be defined as a PTA between 56-70dB HL (0.5-4 kHz) in the better ear, severe HL will be defined as a PTA between 71-90dB HL (0.5-4 kHz) in the better ear and profound HL will be defined as a PTA above 90+dB HL (0.5-4 kHz) in the better ear. Asymmetry of HL will be defined as a difference in PTA that is greater than 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.
|
|---|---|---|---|
|
Single and Dual Task Stride Length Variability
Single Task Stride Length Variability
|
3.24 percent
Standard Deviation 1.09
|
3.60 percent
Standard Deviation 1.23
|
3.79 percent
Standard Deviation 0.84
|
|
Single and Dual Task Stride Length Variability
Dual Task Stride Length Variability
|
3.94 percent
Standard Deviation 1.27
|
4.96 percent
Standard Deviation 1.62
|
3.89 percent
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: 60 second of walkingVariability 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).
Outcome measures
| Measure |
Control Participants With Normal Hearing.
n=28 Participants
Adults aged 40 and older with normal hearing will be defined as a PTA below 25dB (0.5-4 kHz) bilaterally.
|
Mild Bilateral Symmetrical Hearing Loss
n=16 Participants
Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical Mild HL in the past three month and on.
Mild hearing will be defined as a PTA between 26-40dB HL (0.5-4 kHz) in the better ear.
|
>Moderate Bilateral Symmetrical Hearing Loss
n=14 Participants
Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical moderate, moderately-severe, severe, or profound sensorineural HL in the past three month and on.
Moderate hearing will be defined as a PTA between 41-55dB HL (0.5-4 kHz) in the better ear, moderately-severe hearing will be defined as a PTA between 56-70dB HL (0.5-4 kHz) in the better ear, severe HL will be defined as a PTA between 71-90dB HL (0.5-4 kHz) in the better ear and profound HL will be defined as a PTA above 90+dB HL (0.5-4 kHz) in the better ear. Asymmetry of HL will be defined as a difference in PTA that is greater than 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.
|
|---|---|---|---|
|
Single and Dual Task Stride Time Variability
Single Task Stride Time Variability
|
2.07 percent
Standard Deviation 0.56
|
2.37 percent
Standard Deviation 0.71
|
2.31 percent
Standard Deviation 0.62
|
|
Single and Dual Task Stride Time Variability
Dual Task Stride Time Variability
|
3.34 percent
Standard Deviation 1.17
|
3.59 percent
Standard Deviation 0.12
|
3.60 percent
Standard Deviation 1.33
|
Adverse Events
Normal Hearing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mild BHL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
> Moderate BHL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place