Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT04064333
Eligibility Criteria:
Inclusion Criteria:
* Fluent in the English language
* 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.
* Cognitively and physically able to perform study tasks (spirometry, EMST). If assistance and/or cuing is required, the participant must have a support team who is agreeable to providing this for the duration of the study at time of consent. Support teams may consist of any combination of family, friends, private companions, and VC staff.
* Medical clearance by the participant's most responsible physician (MRP)
Exclusion Criteria:
At time of consent
* General medical exclusions: Any history of hernia, pneumothorax, perforated tympanic membrane, recent surgery, untreated gastroesophageal reflux disease or untreated hypertension.
* Other medical conditions where increased intrathoracic pressure would be contraindicated, on an individual basis, as per participant's MRP
* Cognitively and/or physically unable to perform study tasks, despite support
* Participants who do not consent to videofluoroscopy or for whom videofluoroscopy is contraindicated
After time of consent
* Participants who score PAS \< 3 on pre-test videofluoroscopy
* Inability to complete pre-post testing for at least one primary outcome
* Inability to complete minimum 50 breaths of the weekly protocol, and minimum 400 total breaths through the device over the 8 week program
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
85 Years
Maximum Age:
110 Years
Study:
NCT04064333
Study Brief:
Protocol Section:
NCT04064333