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| ID | Type | Description | Link |
|---|---|---|---|
| 25AARG-NTF-1369514 | Other Grant/Funding Number | Alzheimer's Association |
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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:
Caregivers of individuals with Alzheimer's disease will also complete questionnaires.
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, assessments of hand grip and tongue strength, and completion of questionnaires. Caregivers of those with Alzheimer's disease will also complete questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy community dwelling adults | Healthy adults ≥ 60 years old with no prior history of neurological or respiratory diseases, swallowing 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. |
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| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Voluntary cough peak expiratory flow | A measure of cough strength | During baseline visit at time of enrollment |
| Grip strength | Grip strength be used to quantify clinical frailty using a digital hand dynamometer. |
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Inclusion criteria for AD cohort:
Exclusion Criteria for AD Cohort:
Inclusion criteria for care partners of individuals with AD will be:
Exclusion Criteria for Caregivers of Individuals with AD:
Inclusion criteria for community-dwelling adults will be:
3) no prior history of head and neck surgery/head and neck cancer/radiation to head and neck region 4) no prior history of swallowing difficulties based on participant report. 5) Score ≥25th percentile based on sex/age/education/race on the Montreal Cognitive Assessment (MOCA)
Exclusion Criteria for Healthy Cohort:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cara Donohue, PhD CCC-SLP | Contact | 615-852-5085 | cara.donohue@vumc.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D000084802 | Caregiver Burden |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
| 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. |
| 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. |
| Eating Assessment Tool 10 (EAT-10) | The EAT-10 contains 10 questions (score range: 0-40), higher scores indicate greater impairment. | 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. |
| Caregiver Self-Assessment Questionnaire | Scores range from 0-16 with higher scores indicating greater caregiver burden | During baseline visit at time of enrollment. |
| 3 oz water swallow test | Participants will be given a cup of three ounces of water and instructed to drink the water continuously. Fail criteria includes interrupted drinking and/or coughing/throat clearing during or immediately following the drinking task. | During baseline visit at time of enrollment. |
| Reflex cough | Participants will undergo reflex cough testing. | During baseline visit at time of enrollment. |
| Screening for Oral Frailty Tool (SOFT) | Oral frailty will be assessed as present/absent using the Screening for Oral Frailty Tool. | During baseline visit at time of enrollment. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |