Dual-Task Cost in Bilateral Hearing Loss

NCT05540535 | Completed Results

• 1 other identifier: STUDY-21-01026
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 2

Brief Summary

The specific aims of the research study are:

1. 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. 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. 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. 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 \[(DT - single task)/ single task\].

Conditions

Bilateral Hearing Loss; Healthy Aging

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  60 seconds of a walk.

Secondary Outcomes (4)

• Single and Dual Task Stride Length

  60 seconds of a walk.

• Single and Dual Task Stride Time

  60 second of a walk

• Single and Dual Task Stride Length Variability

  60 second of walking

• Single and Dual Task Stride Time Variability

  60 second of walking

Study Arms (3)

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.

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.

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.

Other: Gait assessment; Other: Cognitive assessment

Interventions

Gait assessment OTHER

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.

>Moderate Bilateral Symmetrical Hearing Loss; Control participants with normal hearing.; Mild Bilateral Symmetrical Hearing Loss

Cognitive assessment OTHER

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.

>Moderate Bilateral Symmetrical Hearing Loss; Control participants with normal hearing.; Mild Bilateral Symmetrical Hearing Loss

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York University: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (2)

New York Eye and Ear Infirmary of Mount Sinai

New York, New York, 10010, United States

Location

New York University Physical Therapy Department

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Hearing Loss, Bilateral

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Limitations and Caveats

Lack of statistical power to control for covariates when splitting the BHL group to two. We ended up recruiting mostly well-treated with a high level of education, mostly exercisers and minimal comorbidities therefore findings may only be generalized to a similar demographic and to mild until moderate BHL populations. Challenges in age matching stem from difficulties recruiting young people with BHL and older adults with normal hearing.

Results Point of Contact

• Title: Liraz Arie
• Organization: New York University

la1816@nyu.edu

3478661117

Study Officials

• Anat V Lubetzky, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 14, 2022
• Study Start: February 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: November 22, 2024
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)