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:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT01567020
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-90
* Pure-tone sensitivity of 40 dB HL or better at all audiometric frequencies below 8 kHz
* English as first language.
Group membership inclusion criteria:
Group 1: Blast exposed Veterans
* Report having been exposed to high-intensity blast during the ten years prior to enrollment
* Cognitive and physical ability to take part in these auditory evaluations
Group 2. Non-blast TBI group
* Diagnosed with mild-to-moderate TBI
Group 3. Age matched control group -18-59 years.
Group 4. Older control group
* 60-90 years.
* Older group will be aged 60 and older
Audiometric status of these groups will be required to meet the same exclusion criteria as that of the other two groups described above
Exclusion Criteria:
* Evidence of conductive or retrocochlear dysfunction
* Hearing loss exceeding pure-tone averages for frequencies of .5, 1, 2, and 4 kHz of 35 dB HL
--Hearing loss of greater than 40 dB HL at any one of these frequencies in either ear
* Asymmetrical hearing thresholds exceeding 10 dB at any audiometric frequency below 4 kHz
* Abnormal cognitive function as indicated by scores of 23 or below on the Mini Mental State Exam
* Indications of clinical depression as evidenced by a score of 17 or greater on the Beck Depression Inventory
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01567020
Study Brief:
Protocol Section:
NCT01567020