Optimizing Dysphagia Treatment Delivery in Acute Care: A Hybrid Efficacy Implementation Trial

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT07736105
Status
Not Yet Recruiting

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Conditions

  • Critical Illness
  • Dysphagia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Expiratory muscle strength training (EMST) — BEHAVIORAL
    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 Treatment — BEHAVIORAL
    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 Treatment — BEHAVIORAL
    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 Details

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.

Key Dates

First listed
Jul 30, 2026
Start date
Apr 30, 2027
Status verified
Jul 2026
Primary completion
Oct 31, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Expiratory muscle strength training (EMST)
    Critically ill adults will complete EMST as prescribed.
  • Active Comparator: Standard of Care Dysphagia Treatment
    Critically ill adults will receive dysphagia treatment per standard of care.
  • Experimental: Intensive Dysphagia Treatment
    Critically ill adults will complete intensive dysphagia treatment as prescribed.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Cara Donohue, PhD CCC-SLP
[email protected]
615-852-5085

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