Prevalence and Detection of Voice and Swallowing Disorders in Adults With and Without Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 120
- 主要终点
- Voluntary cough peak expiratory flow
研究概览
简要总结
This research study is investigating whether people with Alzheimer's disease experience more changes to voice and swallowing than their healthy age-matched peers. The prevalence of swallowing impairments in moderate-severe Alzheimer's Disease is high (85-93%) and voice is also often negatively impacted by Alzheimer's disease. The overall objective of this study is to evaluate the voice and swallowing function of adults with and without Alzheimer's disease. The investigators will also be involving the primary caregivers of individuals with Alzheimer's that are enrolled in the study to better understand the impact of voice and swallowing impairments on the primary caregivers of those with Alzheimer's Disease.
Healthy adults and individuals with Alzheimer's disease will:
- undergo tests of cough, voice, and swallow function
- undergo tests of grip and tongue strength
- complete questionnaires
Caregivers of individuals with Alzheimer's disease will also complete questionnaires.
详细描述
This study will involve one in-person research visit that will last approximately 1-1.5 hours and will consist of a screening, cough testing, swallow function testing, vocal function testing, assessments of hand grip and tongue strength, and completion of questionnaires. Caregivers of those with Alzheimer's disease will also complete questionnaires at this initial visit.
Following the first research evaluation visit, individuals will be contacted via email or by phone annually for two consecutive years to complete the same questionnaires completed at the initial visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Voluntary cough peak expiratory flow
时间窗: During baseline visit at time of enrollment.
A measure of cough strength
Swallowing safety
时间窗: During baseline visit at time of enrollment.
The penetration aspiration scale is a validated 8-point ordinal rating scale that measures the depth of airway invasion and the patient's response during swallowing. Scores range from 1 to 8 with a score of 1 indicating a safe swallow (best score) and 8 indicating silent aspiration (worst score).
Vocal fold bowing index
时间窗: During baseline visit at time of enrollment.
Vocal fold bowing will be completed as described by Bloch and Behrman.
次要结局
- Voice Handicap Index (VHI)(During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.)
- Aging Voice Index (AVI)(During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.)
- Tongue strength(During baseline visit at time of enrollment.)
- Clinical frailty scale(During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.)
- Caregiver Self-Assessment Questionnaire(During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.)
- Grip Strength(During baseline visit at time of enrollment.)
- Swallowing and Eating Related Fatigue Questionnaire (SERF)(During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.)
- Swallowing Related Quality of Life Questionnaire (SWAL-QOL)(During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.)
- Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Questionnaire(During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.)
研究者
Cara Donohue, Ph.D. CCC-SLP
Assistant Professor, Director of Medical Speech-Language Pathology
Vanderbilt University Medical Center