DysphagiaNCT07005037
Swallowing Impairments in ICU Survivors and Community-Dwelling Adults
An observational study of Dysphagia and Healthy Aging, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Post-intensive care syndrome (PICS), which consists of physical, cognitive, and psychosocial problems, is a pervasive complication for older intensive care unit (ICU) survivors and contributes to detrimental health outcomes and significant reductions in quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Healthy Aging, Post Intensive Care Syndrome
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2027to 30 Jul 2030
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will enroll 100 community dwelling adults who meet inclusion criteria, 180 critically ill adults who meet inclusion criteria, and 180 caregivers of critically ill adults who meet inclusion criteria.
Who may be able to join
- adult ≥18 years old
- no prior history of neurological diseases or respiratory diseases
- no prior history of head and neck surgery/head and neck cancer/radiation to head and neck region
- no prior history of dysphagia.
- adult ≥ 18 years old
- ICU patients requiring monitoring or treatment for respiratory failure and/or shock (e.g., hypovolemic, septic, and/or cardiogenic)
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- cognitive capacity and willingness to provide informed consent
- medically stable for testing (e.g., can sit upright, respiratory status is stable [Sp02 > 90%, off mechanical ventilation or CPAP/BiPAP for > 30 minutes, respiratory rate < 30 bpm], and Richmond Agitation-Sedation Scale score is 0 (awake and alert).
- caregiver of critically ill adult who meets inclusion criteria for study
- willing to complete questionnaire.
Who cannot join
- <18 years old
- neurological disease or respiratory disease diagnosis
- history of head and neck cancer/surgery to the head and neck region
- history of dysphagia.
- neurological disease diagnosis
- history of head and neck cancer/surgery to the head and neck region
Show all 9Show fewer
- history of dysphagia prior to ICU admission.
- not a caregiver of critically ill adult
- unwilling to complete questionnaire.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Improving Recovery in Older ICU Survivors: Evaluation of Swallowing Dysfunction and Aspiration Risk
Post-intensive care syndrome (PICS), which consists of physical, cognitive, and psychosocial problems, is a pervasive complication for older intensive care unit (ICU) survivors and contributes to detrimental health outcomes and significant reductions in quality of life. Yet, little is known about the relationship between PICS, swallowing difficulties (dysphagia), and other ICU-related negative outcomes such as frailty and Alzheimer's Disease and Related Dementias (ADRD). The primary purpose of this research study is to determine the prevalence and severity of dysphagia, risk factors for dysphagia development, recovery patterns of dysphagia over time, and the impact of dysphagia on health outcomes, quality of life, and care partner burden in adult ICU survivors with PICS.
Read the detailed description
This study will involve one in-person research visit for community dwelling adults and two research visits for critically ill adults (one in the ICU, one 3-months post-hospital discharge) that will last approximately 1 hour and will consist of a screening, cough testing, swallow function testing, assessments of hand grip and tongue strength, and completion of questionnaires. Caregivers of ICU survivors will complete questionnaires at the 3-month follow up visit.
- Medical subject headings
- Deglutition Disorders, postintensive care syndrome, Caregiver Burden
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 community dwelling adults who meet the inclusion criteria for the study will be enrolled. | |
| ICU survivors and their care partners | Critically ill adults and their care partners who meet inclusion criteria for the study will be enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing safety and efficiency
The validated Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale will be used to measure swallowing safety and efficiency.
Measured: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
Secondary outcomes (10)
Voluntary cough peak expiratory flow
A measure of cough strength
Measured: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
Grip strength
Grip strength be used to quantify clinical frailty using a digital hand dynamometer.
Measured: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
Tongue strength
Tongue strength will be assessed using the Iowa Oral Pressure Instrument (IOPI).
Measured: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
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 for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
Eating Assessment Tool 10 (EAT-10)
The EAT-10 contains 10 questions (score range: 0-40), higher scores indicate greater impairment.
Measured: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
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.
Measured: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
Reflex cough
Participants will undergo reflex cough testing.
Measured: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
Screening for Oral Frailty Tool (SOFT)
Oral frailty will be assessed as present/absent using the Screening for Oral Frailty Tool.
Measured: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
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 for community dwelling adults. 3 months post-hospital discharge for critically ill adults.
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: 3 months post-hospital discharge for care partners of critically ill adults.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Apr 2027 (estimated)
- Primary completion30 Jul 2029 (estimated)
- Study completion30 Jul 2030 (estimated)
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 DysphagiaStudies 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
- NCT07005037
- Sponsor's protocol ID
- 250839
- Status last verified
- May 2026
- First submitted
- 26 May 2025
- Last updated
- 2 Jun 2026
- 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Recovery in Older ICU Survivors: Evaluation of Swallowing Dysfunction and Aspiration Risk
- ClinicalTrials.gov ID
- NCT07005037
- Acronym / sponsor ID
- 250839
- 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
- 1 Apr 2027 (estimated)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 4 Jun 2025 (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.
Post-intensive care syndrome (PICS), which consists of physical, cognitive, and psychosocial problems, is a pervasive complication for older intensive care unit (ICU) survivors and contributes to detrimental health outcomes and significant reductions in quality of life. Yet, little is known about the relationship between PICS, swallowing difficulties (dysphagia), and other ICU-related negative outcomes such as frailty and Alzheimer's Disease and Related Dementias (ADRD). The primary purpose of this research study is to determine the prevalence and severity of dysphagia, risk factors for dysphagia development, recovery patterns of dysphagia over time, and the impact of dysphagia on health outcomes, quality of life, and care partner burden in adult ICU survivors with PICS.
Detailed description
This study will involve one in-person research visit for community dwelling adults and two research visits for critically ill adults (one in the ICU, one 3-months post-hospital discharge) that will last approximately 1 hour and will consist of a screening, cough testing, swallow function testing, assessments of hand grip and tongue strength, and completion of questionnaires. Caregivers of ICU survivors will complete questionnaires at the 3-month follow up visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy community dwelling adults | – | –Healthy community dwelling adults who meet the inclusion criteria for the study will be enrolled. |
| ICU survivors and their care partners | – | –Critically ill adults and their care partners who meet inclusion criteria for the study will be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll 100 community dwelling adults who meet inclusion criteria, 180 critically ill adults who meet inclusion criteria, and 180 caregivers of critically ill adults who meet inclusion criteria.
Key inclusion criteria (10 listed)
- adult ≥18 years old
- no prior history of neurological diseases or respiratory diseases
- no prior history of head and neck surgery/head and neck cancer/radiation to head and neck region
- no prior history of dysphagia.
- adult ≥ 18 years old
Key exclusion criteria (9 listed)
- <18 years old
- neurological disease or respiratory disease diagnosis
- history of head and neck cancer/surgery to the head and neck region
- history of dysphagia.
- neurological disease diagnosis
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 and efficiency
Time frame: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
The validated Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale will be used to measure swallowing safety and efficiency.
10 secondary outcomes
Voluntary cough peak expiratory flow
Time frame: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
Grip strength
Time frame: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
Tongue strength
Time frame: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
Swallowing and Eating Related Fatigue Questionnaire (SERF)
Time frame: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
Eating Assessment Tool 10 (EAT-10)
Time frame: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
3 oz water swallow test
Time frame: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
Reflex cough
Time frame: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
Screening for Oral Frailty Tool (SOFT)
Time frame: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.
Swallowing Related Quality of Life Questionnaire (SWAL-QOL)
Time frame: During baseline visit at time of enrollment for community dwelling adults. 3 months post-hospital discharge for critically ill adults.
Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Questionnaire
Time frame: 3 months post-hospital discharge for care partners of critically ill adults.
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 2 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia and Healthy Aging, run by Vanderbilt University Medical Center at 1 site in United States.
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 10 inclusion and 9 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 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 and efficiency (time frame: During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults.). 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 2 Jun 2026.