N/A
N=67
Dual-Task Cost in Bilateral Hearing Loss
Bilateral Hearing Loss · Healthy Aging
Bottom Line
View on ClinicalTrials.gov: NCT05540535 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Gait Speed (Single Task) Over 1-minute Walk — 1.14; 1.02; 1.1 m/sec — p=<0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Gait assessment (Other); Cognitive assessment (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- New York University
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gait Speed (Single Task) Over 1-minute Walk |
1.14; 1.02; 1.1 | <0.05 sig |
| PRIMARY The Neurocognitive Index |
105.45; 108.15; 107.05 | <0.05 sig |
| PRIMARY Gait Speed (Dual Task {DT}) Over 1-minute Walk |
0.95; 0.84; 0.90 | <0.05 sig |
| SECONDARY Single and Dual Task Stride Length |
1.26; 1.14; 1.20; 1.15; 1.02; 1.09 | <0.05 sig |
| SECONDARY Single and Dual Task Stride Time |
1.10; 1.14; 1.09; 1.23; 1.24; 1.21 | 0.05 |
| SECONDARY Single and Dual Task Stride Length Variability |
3.24; 3.60; 3.79; 3.94; 4.96; 3.89 | 0.05 |
| SECONDARY Single and Dual Task Stride Time Variability |
2.07; 2.37; 2.31; 3.34; 3.59; 3.60 | 0.05 |
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].
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05540535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.