Blast-exposed Veterans With Auditory Complaints
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 363
- 试验地点
- 6
- 主要终点
- Intent to Continue Use
研究概览
简要总结
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.
详细描述
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 with a battery of behavioral and physiologic measures. The potential contributions of co-occurring PTSD also will be evaluated. In a preliminary treatment study, a sub-sample of the targeted Veterans will be fitted with mild-gain hearing aids to determine if they benefit from low-level amplification of high-frequency sounds.
This study consists of two parts. In Part 1, four groups of Veterans, aged 20 - 50 years, will complete a battery of auditory and auditory-related assessments to better understand the deficit sources and patterns. The assessment measures will consist of questionnaires, behavioral tests, and auditory physiologic measures. One group will consist of blast-exposed Veterans with auditory problems but no PTSD. The second group will consist of blast-exposed Veterans with auditory problems plus PTSD. The third group will consist of Veterans with PTSD but no reported auditory problems, and the fourth groups will be a normal control group.
In Part 2 of the study (clinical trial portion), a smaller group of participants from the first and second groups will be fitted with mild-gain open-fit hearing aids to determine if they benefit from mild high-frequency amplification. Changes in hearing handicap and speech perception will be compared from baseline to 6-months post-fitting. Perceived hearing aid benefit, hearing aid use time, and intent to continue use will be measured at the end of a 6-month treatment period. A delayed treatment group will be formed from group 1 and will be followed over a 12-month period with hearing aids fitted at 6 months. The participants will be assigned randomly from Part 1 of the study.
The information obtained from this study will help us understand the auditory problems experienced by blast-exposed Veterans and eventually contribute to the development of an efficient and effective assessment battery and intervention approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Intent to Continue Use
时间窗: 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.
Hearing Handicap Inventory for Adults (HHIA)
时间窗: 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.
Hearing Aid Benefit (Abbreviated Profile of Hearing Aid Benefit, APHAB)
时间窗: 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 subtracting the mean aided scores from the mean unaided scores. Higher benefit scores (e.g., 99% unaided - 25% aided vs. 99% unaided - 50% aided) reflected greater benefit (better outcome) and negative scores were possible. The null hypothesis tested was that no hearing aid benefit would be demonstrated by any of the 3 groups at 6-months post-fitting.
次要结局
- Speech Perception in Quiet and in Noise(The CCT was administered immediately pre-fitting (unaided), 1 week post-fitting (aided), and 6 months post-fitting (aided).)
- Hearing Aid Use Time (Number of Participants With an Average Hearing Aid Use Time of 4 Hours a Day)(Hearing aid use time was collected at 6 months post-fitting.)