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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06328374
Enrollment
0
Registered
2024-03-25
Start date
2024-11-05
Completion date
2024-11-05
Last updated
2024-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy Adult Cohort 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)

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 Inclusion Criteria 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

Design outcomes

Primary

MeasureTime frameDescription
Swallowing safetyDuring baseline visit at time of enrollment.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).
Voluntary cough peak expiratory flowDuring baseline visit at time of enrollment.A measure of cough strength
Vocal fold bowing indexDuring baseline visit at time of enrollment.Vocal fold bowing will be completed as described by Bloch and Behrman.

Secondary

MeasureTime frameDescription
Aging Voice Index (AVI)During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.he AVI consists of 23 questions, with scores ranging from 0-92. Higher scores indicate a greater effect of dysphonia on quality of life.
Grip StrengthDuring baseline visit at time of enrollment.Grip strength be used to quantify clinical frailty using a digital hand dynamometer.
Tongue strengthDuring baseline visit at time of enrollment.Tongue strength will be assessed using the Iowa Oral Pressure Instrument (IOPI).
Swallowing and Eating Related Fatigue Questionnaire (SERF)During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.Scores on the SERF range 0-48 with higher scores indicating greater impairment.
Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) QuestionnaireDuring baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.Scores on the CARES range from 0-26 with higher scores indicating greater caregiver burden.
Caregiver Self-Assessment QuestionnaireDuring baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.Scores range from 0-16 with higher scores indicating greater caregiver burden
Clinical frailty scaleDuring baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.The clinical frailty scale (scores 1-9) will be used to classify frailty with higher scores indicating greater impairment.
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.Scores on the SWAL-QOL range from 0-100 with lower scores indicating greater impairment.
Voice Handicap Index (VHI)During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.The VHI contains 30 questions, and scores range from 0-120, with higher scores indicating greater perceived voice handicap.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026