Voice and Swallowing Disorders in Adults With and Without Alzheimer's Disease

Prevalence and Detection of Voice and Swallowing Disorders in Adults With and Without Alzheimer's Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alzheimer Disease; Caregiver Burden; Dysphagia; Healthy Aging; Dysphonia

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Cara Donohue; Phone Number: 615-852-5085; Email: cara.donohue@vumc.org
• Study Contact Backup: Name: Emily Kimball; Email: emily.kimball@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy community dwelling adults; Healthy adults between the ages of 60-100 with no prior history of neurological, respiratory, or gastrointestinal diseases or swallowing or voice impairments, or history of head and neck surgery, cancer, or radiation to the head or neck will be enrolled in this study.
Adults with Alzheimer's Disease and their caregivers; Adults with a diagnosis of Alzheimer's disease and their caregivers will be enrolled in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swallowing safety	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).	During baseline visit at time of enrollment.
Voluntary cough peak expiratory flow	A measure of cough strength	During baseline visit at time of enrollment.
Vocal fold bowing index	Vocal fold bowing will be completed as described by Bloch and Behrman.	During baseline visit at time of enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swallowing and Eating Related Fatigue Questionnaire (SERF)	Scores on the SERF range 0-48 with higher scores indicating greater impairment.	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)	Scores on the SWAL-QOL range from 0-100 with lower scores indicating greater impairment.	During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
Voice Handicap Index (VHI)	The VHI contains 30 questions, and scores range from 0-120, with higher scores indicating greater perceived voice handicap.	During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
Aging Voice Index (AVI)	he AVI consists of 23 questions, with scores ranging from 0-92. Higher scores indicate a greater effect of dysphonia on quality of life.	During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
Grip Strength	Grip strength be used to quantify clinical frailty using a digital hand dynamometer.	During baseline visit at time of enrollment.
Tongue strength	Tongue strength will be assessed using the Iowa Oral Pressure Instrument (IOPI).	During baseline visit at time of enrollment.
Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Questionnaire	Scores on the CARES range from 0-26 with higher scores indicating greater caregiver burden.	During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
Caregiver Self-Assessment Questionnaire	Scores range from 0-16 with higher scores indicating greater caregiver burden	During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
Clinical frailty scale	The clinical frailty scale (scores 1-9) will be used to classify frailty with higher scores indicating greater impairment.	During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Digestive System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Neurocognitive Disorders; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neurodegenerative Diseases; Stress, Psychological; Esophageal Diseases; Dementia; Tauopathies; Laryngeal Diseases; Voice Disorders; Alzheimer Disease; Deglutition Disorders; Caregiver Burden; Dysphonia
• Other Study ID Numbers: 240420

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No