Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT05540535
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT05540535
Study Brief:
Protocol Section:
NCT05540535