Swallowing Impairments in Adults With and Without Alzheimer's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorVanderbilt University Medical Center
About this trial
This research study is investigating whether people with Alzheimer's disease (AD) experience more changes to swallowing than their healthy age-matched peers. The prevalence of swallowing impairments in moderate-severe AD is high (85-93%), yet little is known about how swallow function evolves throughout the disease course in people with AD. The overall objective of this study is to evaluate swallowing function in adults with and without Alzheimer's disease. The investigator will also be involving the primary caregivers of individuals with Alzheimer's that are enrolled in the study to better understand the impact of 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 and swallow function * undergo tests of grip and tongue strength * complete questionnaires
Caregivers of individuals with Alzheimer's disease will also complete questionnaires.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
adult ≥60 years old
diagnosis of AD by a neurologist (confirmed with imaging, spinal tap, behavioral testing)
no prior history of other neurological diseases (aside from stroke which has resolved with no current symptoms)
no prior history of respiratory diseases
Disqualifiers
individual <60 years old
Diagnosis of another type of dementia
History of neurological/respiratory diseases
History of head and neck surgery/head and neck cancer/radiation to head and neck region
Trial population
The overall objective of this proposal is to evaluate swallow function in 80 healthy adults and 80 individuals with AD and to evaluate caregiver perceptions of swallow function and burden in 80 caregivers of individuals with AD. Thus, this study will enroll healthy adults, individuals with AD, and caregivers of individuals with AD.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
240 Participants
are grouped into 2 trial groupsGroup A: Healthy community dwelling adults
Group B: Adults with Alzheimer's Disease and their caregivers
Trial outcomes
Primary outcomes
1
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).
Time frame
During baseline visit at time of enrollment.Secondary outcomes
1
Voluntary cough peak expiratory flow
A measure of cough strength
Time frame
During baseline visit at time of enrollment2
Grip strength
Grip strength be used to quantify clinical frailty using a digital hand dynamometer.
Time frame
During baseline visit at time of enrollment.3
Tongue strength
Tongue strength will be assessed using the Iowa Oral Pressure Instrument (IOPI).
Time frame
During baseline visit at time of enrollment.4
Swallowing and Eating Related Fatigue Questionnaire (SERF)
Scores on the SERF range 0-48 with higher scores indicating greater impairment.
Time frame
During baseline visit at time of enrollment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov