N/A
N=226
Blast Exposed Veterans With Auditory Complaints
Hearing Impairment · Hearing Aid Fitting
Bottom Line
View on ClinicalTrials.gov: NCT02122458 ↗Enrolled (actual)
226
Serious AEs
0.4%
Results posted
Jun 2023
Primary outcome: Primary: Hearing Handicap Inventory for Adults (HHIA) — 26.20; 37.34; 19.21 Scale score — p=.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mild-gain hearing aids with high-frequency emphasis over 6-months (Device)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hearing Handicap Inventory for Adults (HHIA) |
26.20; 37.34; 19.21 | .05 |
| PRIMARY Hearing Aid Benefit (Abbreviated Profile of Hearing Aid Benefit, APHAB) |
-.362; -.270; -.080 | .05 |
| PRIMARY Intent to Continue Use |
9; 13; 7 | — |
| SECONDARY Hearing Aid Use Time (Number of Participants With an Average Hearing Aid Use Time of 4 Hours a Day) |
9; 7; 3 | — |
| SECONDARY Speech Perception in Quiet and in Noise |
.92; .93; .95; .69; .73; .72 | — |
Summary
The purpose of this study is to study blast-exposed Veterans who report hearing handicap but show normal or near normal results on standard audiometric testing. The characteristics and nature of their auditory and auditory-related skills will be examined, along with whether coexisting PTSD contributes to the hearing problems of these Veterans. In a preliminary treatment study, a sub-sample of these Veterans will be fitted with mild-gain hearing aids to determine if they benefit from low-level amplification of high-frequency sounds.
Eligibility Criteria
Inclusion Criteria
- age 20 - 50 years; U.S. Veteran;
- English-speaking;
- history of blast exposure and no history of blast exposure;
- history of PTSD and no history of PTSD;
- self-perceived hearing handicap and no self-perceived hearing handicap;
- normal or near normal pure tone hearing thresholds;
- history of brain injury and no history of brain injury;
- normal vision.
Exclusion Criteria
- hyperacusis;
- marked tinnitus;
- pure tone hearing thresholds consistent with a hearing loss;
- greater the 20/30 vision screening results (corrected or uncorrected);
- marked speech perception deficits
Data sourced from ClinicalTrials.gov (NCT02122458). 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.