Trial Outcomes & Findings for Central Auditory Processing Disorders Associated With Blast Exposure (NCT NCT00554801)

Results Overview

Audiometric testing, with normal hearing specified as better (lower) than 25 decibels Hearing Level (dBHL), and a mild hearing loss between 25 to 50 dBHL.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

84 participants

Primary outcome timeframe

three years

Results posted on

2018-08-10

Participant Flow

Active duty military who were exposed to a blast while deployed and were patients at Walter Reed Army Medical Center; only mild or no traumatic brain injury

Participant milestones

Participant milestones
Measure	Blast-exposed The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC. Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system.	Control Group No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearing loss
Overall Study STARTED	55	29
Overall Study COMPLETED	36	29
Overall Study NOT COMPLETED	19	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Blast-exposed The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC. Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system.	Control Group No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearing loss
Overall Study left area before completion	5	0
Overall Study Withdrawal by Subject	14	0

Baseline Characteristics

Central Auditory Processing Disorders Associated With Blast Exposure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blast-exposed n=36 Participants The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC. Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system.	Control Group n=29 Participants No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearing loss	Total n=65 Participants Total of all reporting groups
Age, Continuous	32.8 years n=5 Participants	32.1 years n=7 Participants	32.5 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	26 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	29 participants n=7 Participants	65 participants n=5 Participants

PRIMARY outcome

Timeframe: three years

Audiometric testing, with normal hearing specified as better (lower) than 25 decibels Hearing Level (dBHL), and a mild hearing loss between 25 to 50 dBHL.

Outcome measures

Outcome measures
Measure	Blast-exposed n=36 Participants The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC. Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system.	Control Group n=29 Participants No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearing loss
Audiological Test Results	10.8 decibels Hearing Level Standard Deviation 6.0	6.6 decibels Hearing Level Standard Deviation 4.2

SECONDARY outcome

Timeframe: Three years

Population: It was decided early during implementation of this study that the investigators would not collect self-report data on quality of life, so there are no data to report

Self-report questionnaires regarding quality of life

Outcome measures

Outcome data not reported

Adverse Events

Blast-exposed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marjorie R. Leek

Portland VA Medical Center

Phone: 503-220-8262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place