← Back to Search

Behavioural Intervention

Expiratory Muscle Training for Swallowing Disorders

N/A

Waitlist Available

Led By Jessica Davenport, MHSc, S-LP

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Identified by their speech-language pathologist as at risk for laryngeal penetration/aspiration when drinking thin liquids

A Penetration Aspiration Scale score of 3+ on at least one thin liquid bolus during pre-test videofluoroscopy, as rated live at the time of test by the speech-language pathologist conducting the videofluoroscopy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post-intervention

Awards & highlights

Study Summary

This trial will test whether a modified 8-week expiratory muscle strength training program can help improve swallowing safety and lung function in elderly veterans with swallowing disorders, compared to no intervention.

Who is the study for?

This trial is for English-speaking veterans with swallowing difficulties living in long-term care at Sunnybrook Veterans Centre. They must be able to perform study tasks or have a support team, and get medical clearance. Those at risk of food/liquid entering their lungs and with certain scores on a swallowing test can join. People with conditions like hernias, lung issues, recent surgeries, untreated reflux or hypertension cannot participate.Check my eligibility

What is being tested?

The study tests if slow-stream expiratory muscle strength training (EMST) over eight weeks helps elderly residents improve cough function and reduce aspiration risks during swallowing. It involves using a hand-held device to strengthen breathing muscles, measured by cough under spirometry and swallowing safety under videofluoroscopy.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from using the resistance device or fatigue due to the exercises involved in EMST. Increased intrathoracic pressure could potentially exacerbate underlying health issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My speech therapist says I might choke on thin liquids.

Select...

I have trouble swallowing thin liquids, confirmed by a special X-ray test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-treatment baseline, 10 weeks after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-treatment baseline, 10 weeks after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment baseline, 10 weeks after baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Penetration Aspiration Scale (PAS)

Voluntary Cough Volume Acceleration

Secondary outcome measures

Dysphagia Handicap Index Emotional Subscale (DysHI-E)

International Dysphagia Diet Standardization Initiative Functional Diet Scale (IDDSI-FDS)

Other outcome measures

Incidence of Respiratory Tract Infections Requiring Antibiotics

Trial Design

1Treatment groups

Experimental Treatment

Group I: Slow-Stream Expiratory Muscle Strength TrainingExperimental Treatment1 Intervention

The therapy protocol consists of 12 sets of five breaths through the EMST150 device per week, in sessions of three or four sets (15 or 20 breaths). A typical schedule might be one 15 breath session four days per week, or one 20 breath session three days per week.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,550,602 Total Patients Enrolled

Jessica Davenport, MHSc, S-LPPrincipal InvestigatorSpeech-Language Pathologist, Sunnybrook

Lisa DiProspero, MRT BSc MScStudy DirectorDirector, Practice-Based Research and Innovation

Media Library

Slow-Stream Expiratory Muscle Strength Training (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04064333 — N/A

Oropharyngeal Dysphagia Research Study Groups: Slow-Stream Expiratory Muscle Strength Training

Oropharyngeal Dysphagia Clinical Trial 2023: Slow-Stream Expiratory Muscle Strength Training Highlights & Side Effects. Trial Name: NCT04064333 — N/A

Slow-Stream Expiratory Muscle Strength Training (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04064333 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could individuals who are under sixty years of age participate in this medical trial?

"The entrance requirements for this study specify that qualified applicants must be between 85 and 110 years of age. There are 38 trials available for individuals below 18, while 476 exist for those above 65."

Answered by AI

Is this medical research study still available to enroll volunteers?

"Contrary to what is posted on clinicaltrials.gov, this particular trial has already ceased accepting patients as of August 12th 2022. Despite that, there are still 516 ongoing medical trials actively recruiting participants at the present moment."

Answered by AI

Who has the eligibility to partake in this clinical trial?

"This clinical trial seeks to enrol 20 individuals aged between 85 and 110 who have dysphagia. In order for potential participants to be accepted, they must meet the following criteria: An aspirational penetration scale score of 3+ on at least one thin liquid bolus during pre-test videofluoroscopy assessed in real time by an SLP, command of English language proficiency, identified risk factors for laryngeal aspiration when drinking thin liquids as determined by a speech therapist, physical and cognitive capacity to complete study tasks including spirometry and EMST with or without assistance from a support network (family/friends), medical clearance from their most"

Answered by AI

Recent research and studies

Journal of the American Medical Directors AssociationJournal

Slow Stream Rehabilitation: A New Model of Post-acute Care

Leung, Grace, Paul R. Katz, Jurgis Karuza, Greg W. Arling, Angela Chan, Anna Berall, Shafagh Fallah, Malcolm A. Binns, and Gary Naglie. 2016. “Slow Stream Rehabilitation: A New Model of Post-acute Care”. Journal of the American Medical Directors Association. Elsevier BV. doi:10.1016/j.jamda.2015.10.016.

DysphagiaJournal

A Penetration-aspiration Scale

Rosenbek, John C., Jo Anne Robbins, Ellen B. Roecker, Jame L. Coyle, and Jennifer L. Wood. 1996. “A Penetration-aspiration Scale”. Dysphagia. Springer Science and Business Media LLC. doi:10.1007/bf00417897.

DysphagiaJournal

Radiation Risks to Adult Patients Undergoing Modified Barium Swallow Studies

Bonilha, Heather Shaw, Walter Huda, Janina Wilmskoetter, Bonnie Martin-Harris, and Sameer V. Tipnis. 2019. “Radiation Risks to Adult Patients Undergoing Modified Barium Swallow Studies”. Dysphagia. Springer Science and Business Media LLC. doi:10.1007/s00455-019-09993-w.

GerodontologyJournal