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

NCT06328374 | Withdrawn

• 1 other identifier: 240420
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Swallowing and Eating Related Fatigue Questionnaire (SERF)

  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)

  During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.

• Voice Handicap Index (VHI)

  During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.

• Aging Voice Index (AVI)

  During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.

• Grip Strength

  During baseline visit at time of enrollment.

Study Arms (2)

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.

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• individual \<60 years old, \>100 years old
• history of neurological disease
• history of respiratory disease
• history of head and neck surgery/head and neck cancer/radiation to head and neck region
• history of swallowing difficulties
• history of gastroesophageal diseases/impairments
• presence of vocal fold lesions or paresis/paralysis
• recent intubation (\<3 weeks)
• score \<26 on the Montreal Cognitive Assessment (MOCA) or the telephone version of the MOCA (t-MOCA)
• AD Cohort
• between 60-100 years old
• diagnosis of AD by neurologist
• consuming some form of oral intake
• able to follow basic directions
• individual \<60 years old, \>100 years old

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

MeSH Terms

Conditions

Alzheimer Disease; Caregiver Burden; Dysphonia; Deglutition Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior; Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Director of Medical Speech-Language Pathology

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: November 5, 2024
• Primary Completion: November 5, 2024
• Study Completion: November 5, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share