DysphagiaNCT07736105
Optimizing Dysphagia Treatment Delivery in Acute Care: A Hybrid Efficacy Implementation Trial
A study testing Expiratory muscle strength training (EMST) and Intensive Dysphagia Treatment in people with Dysphagia and Critical Illness, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This research study is investigating the efficacy and implementation of expiratory muscle strength training (EMST), standard of care dysphagia treatment, and intensive dysphagia treatment in critically ill adults in the acute care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Critical Illness
- What is being tested?
- Expiratory muscle strength training (EMST) and Intensive Dysphagia Treatment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2027to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ≥ 18 years old
- Not pregnant
- Underwent a clinical flexible endoscopic evaluation of swallowing (FEES) or videofluoroscopy swallow study (VFSS) with a penetration aspiration scale (PAS) score ≥ 5
- Hospitalized in non-neuro intensive care unit (ICU) setting at Vanderbilt University Medical Center (VUMC) at some point during admission
- Dysphagia is primarily related to ICU stay and not other medical conditions that may cause dysphagia
- medically cleared with no contraindications for expiratory muscle strength training (EMST) or other treatments
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- Cognitive capacity to follow basic directions
- Willing to undergo testing and treatment for the study.
- Inclusion criteria for speech-language pathologists (SLPs) will be:
- Adult acute care speech-language pathologist who works at VUMC.
- Willing to complete surveys and/or participate in a focus group.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Cara Donohue, PhD CCC-SLP, 615-852-5085, cara.donohue@vumc.org
About this study
This research study is investigating the efficacy and implementation of expiratory muscle strength training (EMST), standard of care dysphagia treatment, and intensive dysphagia treatment in critically ill adults in the acute care setting. Currently, no targeted, effective, and feasible dysphagia treatment approaches currently exist for use in critically ill adults in the acute care setting. The current study will investigate the impact of EMST, standard of care dysphagia treatment, and intensive dysphagia treatment on pulmonary function, cough function, swallow function, frailty, patient-reported swallow function, and health outcomes in critically ill adults. This study will also examine patient perceptions and clinical speech-language pathologists' perceptions of the acceptability, appropriateness, and feasibility of these interventions.
Critically ill adults will: undergo tests of breathing, cough, and swallow function, complete questionnaires about the treatment, and their swallow function, and complete their respective treatment as prescribed.
Read more
Clinical speech-language pathologists will complete questionnaires about the interventions.
A subset of critically ill adults and clinical speech-language pathologists will also have the opportunity to participate in focus groups.
Read the detailed description
This study will involve two in-person research evaluations in the hospital that will last 45 minutes- 1 hour and will consist of a screening, breathing and cough testing, swallow function testing, measures of frailty, and completion of questionnaires. Following the initial research evaluation, critically ill adults will complete the intervention they are assigned to as prescribed. The exercises will take 15-20 minutes to complete and adherence to treatment will be tracked. Prior to hospital discharge and after completion of the intervention, critically ill adults will undergo a second research evaluation.
Clinical speech-language pathologists will complete questionnaires about the interventions that will take 10-15 minutes.
A subset of critically ill adults and clinical speech-language pathologists will also have the opportunity to participate in focus groups, which will take 45 minutes-1 hour.
- Conditions
- Dysphagia, Critical Illness
- Being tested
- Expiratory muscle strength training (EMST), Standard of Care Dysphagia Treatment, Intensive Dysphagia Treatment
- Keywords
- Dysphagia, Swallowing, Deglutition, Deglutition Disorders, Swallowing Disorders, Breathing, Cough, Critical Illness, Treatment
- Medical subject headings
- Deglutition Disorders, Critical Illness, Respiratory Aspiration, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory muscle strength training (EMST)Device
EMST devices will be set to 60% of participants' maximum expiratory pressure. Participants will complete training 5 days per week by performing 5 sets of 5 repetitions.
Standard of Care Dysphagia TreatmentBehavioural
Critically ill adults will perform one set of ten repetitions of each exercise recommended by their clinical speech-language pathologist. Enrolled participants will complete up to two training sessions per week (0-2 pending normal clinical care course) with a clinical speech-language pathologist
Intensive Dysphagia TreatmentBehavioural
Critically ill adults will perform one set of ten repetitions of each exercise (effortful swallow, Masako maneuver, Mendelsohn maneuver, chin tuck against resistance, tongue strengthening exercises, and may also participate in bolus driven therapy). Enrolled participants will complete five training sessions per week (at least 3 days/week with the PI or a trained member of the research team and up to 2 days/week with a member of the clinical speech-language pathology team).
| Study group | Role | What they receive |
|---|---|---|
| Expiratory muscle strength training (EMST) | Experimental | Critically ill adults will complete EMST as prescribed. Receives: Device: Expiratory muscle strength training (EMST) |
| Standard of Care Dysphagia Treatment | Active comparator | Critically ill adults will receive dysphagia treatment per standard of care. Receives: Behavioral: Standard of Care Dysphagia Treatment |
| Intensive Dysphagia Treatment | Experimental | Critically ill adults will complete intensive dysphagia treatment as prescribed. Receives: Behavioral: Intensive Dysphagia Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dynamic Imaging Grade of Swallowing Toxicity Scale (DIGEST) Grades
The DIGEST is a validated, 5-point ordinal rating scale that quantifies global pharyngeal swallow function.
Measured: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Change in Penetration Aspiration Scale Scores
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: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Secondary outcomes (9)
Change in maximum expiratory pressure
A measure of respiratory strength while breathing out
Measured: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Change in cough peak expiratory flow
A measure of cough strength
Measured: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Grip strength
Change in Grip strength be used to quantify clinical frailty using a digital hand dynamometer.
Measured: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Change in Swallowing and Eating Related Fatigue Questionnaire (SERF)
Scores on the SERF range 0-48 with higher scores indicating greater impairment.
Measured: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Change in Screening for Oral Frailty Tool (SOFT)
Oral frailty will be assessed as present/absent using the Screening for Oral Frailty Tool.
Measured: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Change in Eating Assessment Tool 10 (EAT-10)
The EAT-10 contains 10 questions (score range: 0-40), higher scores indicate greater impairment.
Measured: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Acceptability of Intervention Measure (AIM)
A measure of how acceptable an intervention is with scores ranging from 4-20.
Measured: post-treatment prior to hospital discharge, assessed up to 2 weeks
Intervention Appropriateness Measure (IAM)
A measure of how appropriate an intervention is with scores ranging from 4-20.
Measured: post-treatment prior to hospital discharge, assessed up to 2 weeks
Feasibility of Intervention Measure (FIM)
A measure of how feasible an intervention is with scores ranging from 4-20.
Measured: post-treatment prior to hospital discharge, assessed up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study startJul 2027 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionFeb 2029 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
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
- Investigators
- Cara Donohue, PhD CCC-SLP, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736105
- Sponsor's protocol ID
- 261042
- Status last verified
- Oct 2026
- First submitted
- 22 Jul 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Dysphagia Treatment Delivery in Acute Care: A Hybrid Efficacy Implementation Trial
- ClinicalTrials.gov ID
- NCT07736105
- Acronym / sponsor ID
- 261042
- Conditions
- Dysphagia, Critical Illness
- Keywords
- Dysphagia, Swallowing, Deglutition, Deglutition Disorders, Swallowing Disorders, Breathing, Cough, Critical Illness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jul 2027 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 30 Jul 2026 (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 the efficacy and implementation of expiratory muscle strength training (EMST), standard of care dysphagia treatment, and intensive dysphagia treatment in critically ill adults in the acute care setting. Currently, no targeted, effective, and feasible dysphagia treatment approaches currently exist for use in critically ill adults in the acute care setting. The current study will investigate the impact of EMST, standard of care dysphagia treatment, and intensive dysphagia treatment on pulmonary function, cough function, swallow function, frailty, patient-reported swallow function, and health outcomes in critically ill adults. This study will also examine patient perceptions and clinical speech-language pathologists' perceptions of the acceptability, appropriateness, and feasibility of these interventions.
Critically ill adults will: undergo tests of breathing, cough, and swallow function, complete questionnaires about the treatment, and their swallow function, and complete their respective treatment as prescribed.
Clinical speech-language pathologists will complete questionnaires about the interventions.
A subset of critically ill adults and clinical speech-language pathologists will also have the opportunity to participate in focus groups.
Detailed description
This study will involve two in-person research evaluations in the hospital that will last 45 minutes- 1 hour and will consist of a screening, breathing and cough testing, swallow function testing, measures of frailty, and completion of questionnaires. Following the initial research evaluation, critically ill adults will complete the intervention they are assigned to as prescribed. The exercises will take 15-20 minutes to complete and adherence to treatment will be tracked. Prior to hospital discharge and after completion of the intervention, critically ill adults will undergo a second research evaluation.
Clinical speech-language pathologists will complete questionnaires about the interventions that will take 10-15 minutes.
A subset of critically ill adults and clinical speech-language pathologists will also have the opportunity to participate in focus groups, which will take 45 minutes-1 hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Expiratory muscle strength training (EMST) | Experimental | Device: Expiratory muscle strength training (EMST)Critically ill adults will complete EMST as prescribed. |
| Standard of Care Dysphagia Treatment | Active comparator | Behavioral: Standard of Care Dysphagia TreatmentCritically ill adults will receive dysphagia treatment per standard of care. |
| Intensive Dysphagia Treatment | Experimental | Behavioral: Intensive Dysphagia TreatmentCritically ill adults will complete intensive dysphagia treatment as prescribed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult ≥ 18 years old
- Not pregnant
- Underwent a clinical flexible endoscopic evaluation of swallowing (FEES) or videofluoroscopy swallow study (VFSS) with a penetration aspiration scale (PAS) score ≥ 5
- Hospitalized in non-neuro intensive care unit (ICU) setting at Vanderbilt University Medical Center (VUMC) at some point during admission
- Dysphagia is primarily related to ICU stay and not other medical conditions that may cause dysphagia
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expiratory muscle strength training (EMST)EMST devices will be set to 60% of participants' maximum expiratory pressure. Participants will complete training 5 days per week by performing 5 sets of 5 repetitions. | Device | Expiratory muscle strength training (EMST) |
| Standard of Care Dysphagia TreatmentCritically ill adults will perform one set of ten repetitions of each exercise recommended by their clinical speech-language pathologist. Enrolled participants will complete up to two training sessions per week (0-2 pending normal clinical care course) with a clinical speech-language pathologist | Behavioural | Standard of Care Dysphagia Treatment |
| Intensive Dysphagia TreatmentCritically ill adults will perform one set of ten repetitions of each exercise (effortful swallow, Masako maneuver, Mendelsohn maneuver, chin tuck against resistance, tongue strengthening exercises, and may also participate in bolus driven therapy). Enrolled participants will complete five training sessions per week (at least 3 days/week with the PI or a trained member of the research team and up to 2 days/week with a member of the clinical speech-language pathology team). | Behavioural | Intensive Dysphagia Treatment |
Primary outcome
Change in Dynamic Imaging Grade of Swallowing Toxicity Scale (DIGEST) Grades
Time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
The DIGEST is a validated, 5-point ordinal rating scale that quantifies global pharyngeal swallow function.
Change in Penetration Aspiration Scale Scores
Time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
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).
9 secondary outcomes
Change in maximum expiratory pressure
Time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Change in cough peak expiratory flow
Time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Grip strength
Time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Change in Swallowing and Eating Related Fatigue Questionnaire (SERF)
Time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Change in Screening for Oral Frailty Tool (SOFT)
Time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Change in Eating Assessment Tool 10 (EAT-10)
Time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Acceptability of Intervention Measure (AIM)
Time frame: post-treatment prior to hospital discharge, assessed up to 2 weeks
Intervention Appropriateness Measure (IAM)
Time frame: post-treatment prior to hospital discharge, assessed up to 2 weeks
Feasibility of Intervention Measure (FIM)
Time frame: post-treatment prior to hospital discharge, assessed up to 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 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.
Cara Donohue, PhD CCC-SLP principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expiratory muscle strength training (EMST) and Intensive Dysphagia Treatment in people with Dysphagia and Critical Illness, 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 11 inclusion and 0 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: opening soon, as of the sponsor's last update on 14 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cara Donohue, PhD CCC-SLP (615-852-5085, cara.donohue@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dynamic Imaging Grade of Swallowing Toxicity Scale (DIGEST) Grades (time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks). The study lists 2 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 14 Oct 2026.