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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06328374
• Other study ID #: 240420
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Vanderbilt University Medical Center
• Contact: Cara Donohue
• Phone: 615-852-5085
• Email: cara.donohue[@]vumc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Caregiver Burden
• Deglutition Disorders
• Dysphagia
• Dysphonia
• Healthy Aging

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Voluntary cough peak expiratory flow	A measure of cough strength	During baseline visit at time of enrollment.
Primary	Vocal fold bowing index	Vocal fold bowing will be completed as described by Bloch and Behrman.	During baseline visit at time of enrollment.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Grip Strength	Grip strength be used to quantify clinical frailty using a digital hand dynamometer.	During baseline visit at time of enrollment.
Secondary	Tongue strength	Tongue strength will be assessed using the Iowa Oral Pressure Instrument (IOPI).	During baseline visit at time of enrollment.
Secondary	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.
Secondary	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.
Secondary	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.