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

NCT ID: NCT06328374

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-05
• Study Completion Date: 2024-11-05

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.

Conditions

Alzheimer Disease; Caregiver Burden; Healthy Aging; Dysphonia; Dysphagia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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)

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

1. primary caregiver of an individual with AD

2. willing to complete questionnaires/semi-structured interview

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

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

1. not the primary caregiver of an individual with AD

2. unwilling to complete questionnaires/semi-structured interview

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Cara Donohue, Ph.D. CCC-SLP

Assistant Professor, Director of Medical Speech-Language Pathology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

240420

Identifier Type: -

Identifier Source: org_study_id