Early Age-Related Hearing Loss Investigation Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Objective Physical Activity
研究概览
简要总结
The purpose of this clinical trial pilot is to obtain feasibility and pilot data necessary to inform the hearing intervention being designed for a larger R01 clinical trial that seeks to determine whether best practice hearing aid intervention impacts hearing-related outcomes in adults with hearing loss aged 55 to 75 years.
Secondary purposes include: To determine what effects best practice hearing aid intervention has on physical, social, and quality of life outcomes in adults with hearing loss aged 55 to 75 years.
详细描述
This is an observational pre-post intervention feasibility study. In addition to the objective finding that adults with hearing loss experience higher rates of cognitive decline, they also tend to report lesser degrees of physical activity and increased cognitive fatigue, which is the feeling of tiredness or having a lack of energy. Unfortunately, the mechanism by which hearing loss relates to physical activity and fatigue, and the effect of hearing aids as an intervention to improve these factors, is unclear. Thus, the purpose of this study is twofold: First, we will establish the feasibility of administering a best practices hearing aid intervention to a sample of adults from the target age range of 55 - 75 years old to inform the larger clinical trial; Second, we will collect pilot data to explore the relationships between hearing loss, physical activity, socialization, fatigue and hearing-related outcomes before and after hearing aid intervention.
There are no experimental or investigational devices or agents used in this study. We are providing best-practices standard of care hearing intervention including hearing aids. We are additionally tracking activity using the ActiGraph wGT3X-BT, an FDA-approved Class II medical device that tracks continuous, high resolution physical activity and sleep/wake information.
Participation involves a minimum of 6 in-office study visits. Intervention sessions occur approximately 2 weeks apart, with a final long-term outcome session occurring approximately 6-months post the baseline intervention session.
Significant others of participants are invited to join the study and contribute data related to their own quality of life and their observations of the effects of the hearing intervention on the participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 55 to 75 years old with little or no experience with hearing aids
- •English or Spanish speakers
排除标准
- •Unable to complete written questionnaires on a tablet without assistance
- •Refer for cognitive screening score based on criteria using the Mini Mental State Examination
结局指标
主要结局
Objective Physical Activity
时间窗: 2-week measurement taken between 4- and 6- months post study enrollment
Activity level as measured by research-grade accelerometer
次要结局
- Center for Epidemiological Studies Depression and Hopelessness Scale(Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment)
- Words in Noise Test(Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment)
- UCLA Loneliness Scale(Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment)
- Research & Development Short Form Survey (RAND36)(Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment)
- International Outcome Inventory for Comprehensive Hearing Intervention(Measured at 6-months post study enrollment)
- Hearing Handicap Inventory for Adults(Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment)
- Social Network Index(Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment)
- Expanded short physical performance battery(Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment)
- User Experience Questionnaire+(Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment)
- Client Oriented Scale of Improvement(Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment)
- Modified four-square step test(Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment)
- Baecke Physical Activity Questionnaire(Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment)
- Speech, Spatial and Qualities of Hearing Scale(Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment)
- The Positive and Negative Affect Schedule(Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment)
- The World Health Organization Well-Being Index(Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment)
- The Vanderbilt Fatigue Scale for Adults(Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment)
- Single-item sedentary questionnaire(Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment)
- PROMIS v2.0 Mobility Questionnaire(Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment)
研究者
Michelle Arnold
Assistant Professor
University of South Florida