Alzheimer DiseaseNCT06328374
Voice and Swallowing Disorders in Adults With and Without Alzheimer's Disease
An observational study of Alzheimer Disease and Caregiver Burden, run by Vanderbilt University Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Caregiver Burden, Healthy Aging
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 Nov 2024to 5 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 15Show fewer
- 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)
- between 60-100 years old
- diagnosis of AD by neurologist
- consuming some form of oral intake
- able to follow basic directions
- primary caregiver of an individual with AD
- willing to complete questionnaires/semi-structured interview
Who cannot join
- 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
Show all 17Show fewer
- 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
- individual <60 years old, >100 years old
- diagnosis of another type of dementia
- not consuming any oral intake
- unable to follow basic directions
- Caregivers of Individuals with AD Cohort
- not the primary caregiver of an individual with AD
- unwilling to complete questionnaires/semi-structured interview
About this study
Official title: Prevalence and Detection of Voice and Swallowing Disorders in Adults With and Without Alzheimer's Disease
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:
Read more
- 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.
Read the 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.
- Conditions
- Alzheimer Disease, Caregiver Burden, Healthy Aging, Dysphonia, Dysphagia
- Medical subject headings
- Alzheimer Disease, Caregiver Burden, Dysphonia, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During baseline visit at time of enrollment.
Voluntary cough peak expiratory flow
A measure of cough strength
Measured: During baseline visit at time of enrollment.
Vocal fold bowing index
Vocal fold bowing will be completed as described by Bloch and Behrman.
Measured: During baseline visit at time of enrollment.
Secondary outcomes (9)
Swallowing and Eating Related Fatigue Questionnaire (SERF)
Scores on the SERF range 0-48 with higher scores indicating greater impairment.
Measured: 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)
Scores on the SWAL-QOL range from 0-100 with lower scores indicating greater impairment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During baseline visit at time of enrollment.
Tongue strength
Tongue strength will be assessed using the Iowa Oral Pressure Instrument (IOPI).
Measured: 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.
Measured: 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.
Measured: 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
Measured: During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start5 Nov 2024
- Primary completion5 Nov 2024
- Study completion5 Nov 2024
Why it stopped: Change of scope of the work given feedback from funding agency leading to new IRB/clinicaltrials.gov registration.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cara Donohue, Ph.D. CCC-SLP, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328374
- Sponsor's protocol ID
- 240420
- Status last verified
- Nov 2024
- First submitted
- 18 Mar 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Detection of Voice and Swallowing Disorders in Adults With and Without Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06328374
- Acronym / sponsor ID
- 240420
- Conditions
- Alzheimer Disease, Caregiver Burden, Healthy Aging, Dysphonia, Dysphagia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Change of scope of the work given feedback from funding agency leading to new IRB/clinicaltrials.gov registration.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Swallowing safety
Time frame: During 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 flow
Time frame: During baseline visit at time of enrollment.
A measure of cough strength
Vocal fold bowing index
Time frame: During baseline visit at time of enrollment.
Vocal fold bowing will be completed as described by Bloch and Behrman.
9 secondary outcomes
Swallowing and Eating Related Fatigue Questionnaire (SERF)
Time frame: 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)
Time frame: During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
Voice Handicap Index (VHI)
Time frame: During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
Aging Voice Index (AVI)
Time frame: During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
Grip Strength
Time frame: During baseline visit at time of enrollment.
Tongue strength
Time frame: During baseline visit at time of enrollment.
Clinical frailty scale
Time frame: 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
Time frame: During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
Caregiver Self-Assessment Questionnaire
Time frame: During baseline visit at time of enrollment, 1 year after baseline visit, 2 years after baseline visit.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Caregiver Burden, run by Vanderbilt University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing safety (time frame: During baseline visit at time of enrollment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.