Bilateral Hearing LossNCT05540535
Dual-Task Cost in Bilateral Hearing Loss
An observational study of Bilateral Hearing Loss and Healthy Aging, run by New York University at 2 sites in United States.
Trial 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)]. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bilateral Hearing Loss, Healthy Aging
- What is being tested?
- Gait assessment and Cognitive assessment
- How many people
- 67 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2022to 22 Nov 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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. Normal hearing will be 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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, 10010
New York University Physical Therapy Department
New York, New York, 10010
About this study
Official title: Dual-Task Cost During Walking in People With Hearing Loss Compared to Normal Hearing
The specific aims of the research study are:
- 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.
- 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.
- 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.
- 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].
Read the 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.
- Conditions
- Bilateral Hearing Loss, Healthy Aging
- Being tested
- Gait assessment, Cognitive assessment
- Medical subject headings
- Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait assessmentOther
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.
Cognitive assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control participants with normal hearing. | Adults aged 40 and older with normal hearing will be defined as a PTA below 25dB (0.5-4 kHz) bilaterally. Receives: Other: Gait assessment; Other: Cognitive assessment | |
| Mild Bilateral Symmetrical Hearing Loss | Adults aged 40 and older with a clinical diagnosis of bilateral symmetrical mild HL in the past three month and on will be defined as a PTA between 26-40dB HL (0.5-4 kHz) in the better ear. Receives: Other: Gait assessment; Other: Cognitive assessment | |
| >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. Receives: Other: Gait assessment; Other: Cognitive assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 seconds of a walk.
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.
Measured: 30 minutes of assessment.
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.
Measured: 60 seconds of a walk.
Secondary outcomes (4)
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).
Measured: 60 seconds of a walk.
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.
Measured: 60 second of a walk
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).
Measured: 60 second of walking
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).
Measured: 60 second of walking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Feb 2022
- Primary completion30 Sep 2023
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bilateral Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Anat V Lubetzky, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540535
- Sponsor's protocol ID
- STUDY-21-01026
- Status last verified
- Nov 2023
- First submitted
- 12 Sep 2022
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Task Cost During Walking in People With Hearing Loss Compared to Normal Hearing
- ClinicalTrials.gov ID
- NCT05540535
- Acronym / sponsor ID
- STUDY-21-01026
- Conditions
- Bilateral Hearing Loss, Healthy Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 14 Sep 2022 (actual)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aims of the research study are:
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control participants with normal hearing. | – | Other: Gait assessment, Other: Cognitive assessmentAdults 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 | – | Other: Gait assessment, Other: Cognitive assessmentAdults aged 40 and older with a clinical diagnosis of bilateral symmetrical mild HL in the past three month and on will be defined as a PTA between 26-40dB HL (0.5-4 kHz) in the better ear. |
| >Moderate Bilateral Symmetrical Hearing Loss | – | Other: Gait assessment, Other: Cognitive assessmentAdults 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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. Normal hearing will be 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait assessmentThe 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. | Other | >Moderate Bilateral Symmetrical Hearing Loss, Control participants with normal hearing., Mild Bilateral Symmetrical Hearing Loss |
| Cognitive assessmentParticipants 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. | Other | >Moderate Bilateral Symmetrical Hearing Loss, Control participants with normal hearing., Mild Bilateral Symmetrical Hearing Loss |
Primary outcome
Gait Speed (Single Task) Over 1-minute Walk
Time frame: 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
Time frame: 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
Time frame: 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.
4 secondary outcomes
Single and Dual Task Stride Length
Time frame: 60 seconds of a walk.
Single and Dual Task Stride Time
Time frame: 60 second of a walk
Single and Dual Task Stride Length Variability
Time frame: 60 second of walking
Single and Dual Task Stride Time Variability
Time frame: 60 second of walking
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Bilateral Hearing Loss
Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
Bilateral Hearing Loss, Health Services Research
Active, not recruiting
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Hearing Loss, Sensorineural, Hearing Loss
Recruiting
Towards Implementation of Universal Newborn Hearing Screening in Kenya
Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
Active, not recruiting
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
Hearing Loss, Bilateral Sensorineural
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anat V Lubetzky, PhD principal investigator
New York University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bilateral Hearing Loss and Healthy Aging, run by New York University at 2 sites in United States.
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 7 inclusion and 12 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 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Gait Speed (Single Task) Over 1-minute Walk (time frame: 60 seconds of a walk.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2025.