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Change of scope of the work given feedback from funding agency leading to new IRB/clinicaltrials.gov registration.
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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:
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, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Swallowing Related Quality of Life Questionnaire (SWAL-QOL) |
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Healthy Adult Cohort
Inclusion Criteria
Exclusion Criteria
AD Cohort
Inclusion Criteria
Exclusion Criteria
Caregivers of Individuals with AD Cohort
Inclusion Criteria
Exclusion Criteria
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 22, 2024 | May 31, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D000084802 | Caregiver Burden |
| D055154 | Dysphonia |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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. |
| 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. |
| 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. |
| Grip Strength | Grip strength be used to quantify clinical frailty using a digital hand dynamometer. | 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. |
| 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. |
| 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. |
| 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. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |