Clinical trial NCT06328374: Voice and Swallowing Disorders in Adults With and Without Alzheimer's Disease
Official title: Prevalence and Detection of Voice and Swallowing Disorders in Adults With and Without Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Alzheimer Disease
Caregiver Burden
Healthy Aging
Dysphonia
Dysphagia
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The overall objective of this proposal is to evaluate voice and swallow function in 40 healthy adults and 40 individuals with AD and to evaluate caregiver perceptions of voice and swallow function and burden in 40 caregivers of individuals with AD. Thus, this study will enroll healthy adults, individuals with AD, and caregivers of individuals with AD.

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.

Eligibility criteria: Healthy Adult Cohort

Inclusion Criteria

1. healthy community dwelling adult (60-100 years old)
2. no prior history of neurological diseases
3. no prior history of respiratory diseases
4. no prior history of head and neck surgery/head and neck cancer/radiation to head and neck region
5. no prior history of swallowing difficulties
6. no prior history of gastroesophageal diseases/impairments
7. absence of vocal fold lesions or paresis/paralysis
8. no recent intubation (≥3 weeks)
9. score ≥26 on the Montreal Cognitive Assessment (MOCA) or the telephone version of the MOCA (t-MOCA)

Exclusion Criteria

1. individual \<60 years old, \>100 years old
2. history of neurological disease
3. history of respiratory disease
4. history of head and neck surgery/head and neck cancer/radiation to head and neck region
5. history of swallowing difficulties
6. history of gastroesophageal diseases/impairments
7. presence of vocal fold lesions or paresis/paralysis
8. recent intubation (\<3 weeks)
9. score \<26 on the Montreal Cognitive Assessment (MOCA) or the telephone version of the MOCA (t-MOCA)

AD Cohort

Inclusion Criteria

1. between 60-100 years old
2. diagnosis of AD by neurologist
3. consuming some form of oral intake
4. able to follow basic directions

Exclusion Criteria

1. individual \<60 years old, \>100 years old
2. diagnosis of another type of dementia
3. not consuming any oral intake
4. unable to follow basic directions

Caregivers of Individuals with AD Cohort

Inclusion Criteria

1. primary caregiver of an individual with AD
2. willing to complete questionnaires/semi-structured interview

Exclusion Criteria

1. not the primary caregiver of an individual with AD
2. unwilling to complete questionnaires/semi-structured interview

Primary outcomes:
measure: Swallowing safety
timeFrame: During baseline visit at time of enrollment.
measure: Voluntary cough peak expiratory flow
timeFrame: During baseline visit at time of enrollment.
measure: Vocal fold bowing index
timeFrame: During baseline visit at time of enrollment.
Secondary outcomes:
measure: Swallowing and Eating Related Fatigue Questionnaire (SERF)
timeFrame: During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
measure: Swallowing Related Quality of Life Questionnaire (SWAL-QOL)
timeFrame: During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
measure: Voice Handicap Index (VHI)
timeFrame: During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
measure: Aging Voice Index (AVI)
timeFrame: During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
measure: Grip Strength
timeFrame: During baseline visit at time of enrollment.
measure: Tongue strength
timeFrame: During baseline visit at time of enrollment.
measure: Clinical frailty scale
timeFrame: During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
measure: Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Questionnaire
timeFrame: During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
measure: Caregiver Self-Assessment Questionnaire
timeFrame: During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
Other outcomes:
Locations:
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