Voice and Swallowing Disorders in Adults With and Without Alzheimer's Disease
- Conditions
- DysphoniaDysphagiaAlzheimer DiseaseCaregiver BurdenHealthy Aging
- Registration Number
- NCT06328374
- Lead Sponsor
- Vanderbilt University Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Voluntary cough peak expiratory flow During baseline visit at time of enrollment. A measure of cough strength
Swallowing safety 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 During baseline visit at time of enrollment. Vocal fold bowing will be completed as described by Bloch and Behrman.
- Secondary Outcome Measures
Name Time Method Voice Handicap Index (VHI) During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit. The VHI contains 30 questions, and scores range from 0-120, with higher scores indicating greater perceived voice handicap.
Aging Voice Index (AVI) During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit. he AVI consists of 23 questions, with scores ranging from 0-92. Higher scores indicate a greater effect of dysphonia on quality of life.
Tongue strength During baseline visit at time of enrollment. Tongue strength will be assessed using the Iowa Oral Pressure Instrument (IOPI).
Clinical frailty scale During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit. The clinical frailty scale (scores 1-9) will be used to classify frailty with higher scores indicating greater impairment.
Caregiver Self-Assessment Questionnaire During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit. Scores range from 0-16 with higher scores indicating greater caregiver burden
Grip Strength During baseline visit at time of enrollment. Grip strength be used to quantify clinical frailty using a digital hand dynamometer.
Swallowing and Eating Related Fatigue Questionnaire (SERF) During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit. Scores on the SERF range 0-48 with higher scores indicating greater impairment.
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. Scores on the SWAL-QOL range from 0-100 with lower scores indicating greater impairment.
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. Scores on the CARES range from 0-26 with higher scores indicating greater caregiver burden.