An interventional study of Expiratory muscle strength training (EMST) and Standard of Care Dysphagia Treatment in Dysphagia and Critical Illness, sponsored by Vanderbilt University Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for critically ill adults will be:
Inclusion criteria for speech-language pathologists (SLPs) will be:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Critically ill adults will complete EMST as prescribed.
Device: Expiratory muscle strength training (EMST)
Critically ill adults will receive dysphagia treatment per standard of care.
Behavioral: Standard of Care Dysphagia Treatment
Critically ill adults will complete intensive dysphagia treatment as prescribed.
Behavioral: Intensive Dysphagia Treatment
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.
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
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).
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.
Time frame: 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).
Time frame: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Change in maximum expiratory pressure
A measure of respiratory strength while breathing out
Time frame: 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
Time frame: 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.
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)
Scores on the SERF range 0-48 with higher scores indicating greater impairment.
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)
Oral frailty will be assessed as present/absent using the Screening for Oral Frailty Tool.
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)
The EAT-10 contains 10 questions (score range: 0-40), higher scores indicate greater impairment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: post-treatment prior to hospital discharge, assessed up to 2 weeks
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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