CompletedNAResults postedLast updated 22 June 2023
What this trial tests
NA trial testing mild-gain hearing aids with high-frequency emphasis over 6-months in Hearing Impairment in 363 participants. Completed in 31 December 2020.
Adults 20 to 50, any sex, with Hearing Impairment or Hearing Aid Fitting. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Hearing Handicap Inventory for Adults (HHIA)Primary· The participants wore their hearing aids for 6 months-fitting (baseline to 6-months post-fitting). The delayed group had a 6-month delay prior to treatment.
Self-perceived hearing handicap was measured with the Hearing Handicap Inventory for Adults (HHIA), pre- and 6-months post-hearing aid fitting. The minimum score is 0 and the maximum score is 100, with the higher score reflecting greater handicap (worse outcome). The data are presented as a comparison between the two questionnaire administrations (pre- and 6-months post-fitting). The null hypothesis tested was that there would be no difference between the HHIA administered at baseline (pre-fitting) and 6-months post-fitting for all groups.
Group
Value
95% CI
Immediate Hearing Aid Treatment: Blast-exposed Only
26.20
19.04 – 33.33
Immediate Hearing Aid Treatment: Blast-exposed With PTSD
37.34
31.37 – 43.32
Delayed Hearing Aid Treatment: Blast-exposed Only
19.21
10.48 – 27.95
Hearing Aid Benefit (Abbreviated Profile of Hearing Aid Benefit, APHAB)Primary· The APHAB was administered 6-months post-fitting. The delayed group had a 6-month delay prior to the treatment (6-months of wearing the hearing aids).
The Abbreviated Profile of Hearing Aid Benefit (APHAB) was administered at the end of the treatment period (6-months post-fitting) to measure self-perceived benefit. The APHAB is a 24-item self-assessment inventory used to indicate the extent to which listeners experience listening difficulties (with and without hearing aids) in various settings. The questionnaire uses a 7-point scale that corresponds to the frequency with which difficulties are experienced (99 to 1% of the time). The APHAB was administered for both unaided listening and aided listening, and benefit was calculated by subtracti
Group
Value
95% CI
Immediate Hearing Aid Treatment: Blast-Exposed Only
-.362
± .301
Immediate Hearing Aid Treatment: Blast-exposed With PTSD
-.270
± .821
Delayed Hearing Aid Treatment: Blast-exposed Only
-.080
± .331
Intent to Continue UsePrimary· 6 months post-fitting
The participants reported whether they would continue to use their hearing aids after the study has ended. The null hypothesis tested was that neither group would demonstrate a significant preference for retaining their hearing aids.
Group
Value
95% CI
Immediate Hearing Aid Treatment: Blast-Exposed Only
9
Immediate Hearing Aid Treatment: Blast-Exposed With PTSD
13
Delayed Hearing Aid Treatment: Blast-exposed Only
7
Hearing Aid Use Time (Number of Participants With an Average Hearing Aid Use Time of 4 Hours a Day)Secondary· Hearing aid use time was collected at 6 months post-fitting.
Hearing aid use time was the number of participants who wore their hearing aids for an average of at least 4 hours per day. The average number of hours that the participants used their hearing aids was measured by their hearing aid data logging systems. These data were collected at the end of the treatment interval for each participant and were considered a positive outcome if they wore their hearing aids at least 4 hours a day on average after 1 month of use. The null hypothesis tested was that none of the participants in the three groups would not demonstrate hearing aid use time 4 hours or
Group
Value
95% CI
Immediate Hearing Aid Treatment: Blast-exposed Only
9
Immediate Hearing Aid Treatment: Blast-exposed With PTSD
7
Delayed Hearing Aid Treatment: Blast-exposed Only
3
Speech Perception in Quiet and in NoiseSecondary· The CCT was administered immediately pre-fitting (unaided), 1 week post-fitting (aided), and 6 months post-fitting (aided).
The participants' speech perception was measured at the word level with the California Consonant Test (CCT). The CCT is a 50 item a closed-set word identification test. It was administered at 3 timepoints (pre-fitting, 1-week post-fitting, and 6-months post-fitting), with testing was completed in quiet and in background noise (speech babble, +3 dB signal/babble) at each timepoint. The participants were unaided during the pre-fitting testing but wore their hearing aids during the two post-fitting sessions. The outcome measure was the proportion of correct trials out of 50. A correct trial consi
Pre-fitting Score in Quiet
Group
Value
95% CI
Immediate Hearing Aid Treatment: Blast-exposed Only
.92
± .017
Immediate Hearing Aid Treatment: Blast-exposed With PTSD
.93
± .013
Delayed Hearing Aid Treatment: Blast-exposed Only
.95
± .018
Pre-fitting Score in Noise
Group
Value
95% CI
Immediate Hearing Aid Treatment: Blast-exposed Only
.69
± .044
Immediate Hearing Aid Treatment: Blast-exposed With PTSD
.73
± .033
Delayed Hearing Aid Treatment: Blast-exposed Only
.72
± .047
1-week Post-fitting Test Score in Quiet
Group
Value
95% CI
Immediate Hearing Aid Treatment: Blast-exposed Only
.96
± .018
Immediate Hearing Aid Treatment: Blast-exposed With PTSD
.93
± .014
Delayed Hearing Aid Treatment: Blast-exposed Only
.95
± .019
1-week Post-fitting Test Score in Noise
Group
Value
95% CI
Immediate Hearing Aid Treatment: Blast-exposed Only
.83
± .046
Immediate Hearing Aid Treatment: Blast-exposed With PTSD
.79
± .035
Delayed Hearing Aid Treatment: Blast-exposed Only
.79
± .049
Final Test Score in Quiet
Group
Value
95% CI
Immediate Hearing Aid Treatment: Blast-exposed Only
.96
± .009
Immediate Hearing Aid Treatment: Blast-exposed With PTSD
.95
± .007
Delayed Hearing Aid Treatment: Blast-exposed Only
.95
± .010
Final Test Score in Noise
Group
Value
95% CI
Immediate Hearing Aid Treatment: Blast-exposed Only
.84
± .037
Immediate Hearing Aid Treatment: Blast-exposed With PTSD
.82
± .028
Delayed Hearing Aid Treatment: Blast-exposed Only
.71
± .040
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were queried for each individual participant per session from enrollment to completion of their participation in study and summarized yearly at IRB renewal, Adverse Events were collected for 6 months from all participants except for those enrolled in the Delayed Hearing Aid Treatment Arm/Group, which was assessed for up to 1 year..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Immediate Hearing Aid Treatment: Blast-exposed Only
Serious: 1/12 (8%)
Deaths: 0/12
Immediate Hearing Aid Treatment: Blast-exposed With PTSD
Serious: 0/18 (0%)
Deaths: 0/18
Delayed Hearing Aid Treatment: Blast-exposed Only
Serious: 0/7 (0%)
Deaths: 0/7
Non-treatment Diagnostic Testing: Normal
Serious: 0/82 (0%)
Deaths: 0/82
Non-treatment Diagnostic Testing: Blast-exposed Only
Serious: 0/45 (0%)
Deaths: 0/45
Non-treatment Diagnostic Testing: Blast-exposed With PTSD
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 22 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02122458.