An interventional study of Noninvasive Ventilation Mask Microphone in Noninvasive Ventilation and Speech Intelligibility, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-01.
Sponsored by University of Utah · Not applicable, Interventional, and Device feasibility
Assessing speech intelligibility in a pilot study of patients speaking with a mask microphone while being treated with standard of care non-invasive ventilation. This is a feasibility study to test the microphone in a real world setting.
We will conduct a prospective feasibility study to evaluate speech intelligibility of 10 patients (target distribution of gender: 5 males, 5 females) undergoing standard of care, clinically indicated non-invasive ventilation. Patients will be their own control with and without the ReddyPort™ microphone using a crossover design, with the sequence of conditions randomized (half of patients start with microphone turned on, half start with the microphone turned off). The patients in this study will all receive standard of care. No medical decisions for a change in care will result from the speech recordings obtained during this feasibility study. The speech recordings will be analyzed off-site using a pool of blinded volunteers. The microphone on and off test conditions will not be used to change outcome of the clinical course of care.
University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient talking with microphone first turned on and then off
Device: Noninvasive Ventilation Mask Microphone
Patient talking with microphone first turned off and then on
Device: Noninvasive Ventilation Mask Microphone
Noninvasive Ventilation Mask Microphone is turned on to enhance speech intelligibility during the intervention portion of the crossover feasibility study
Rating of speech intelligibility
The 1-5 likert scale developed by Yorkston et al will be used to evaluate speech intelligibility of the device (Yorkston, Kathryn M., David R. Beukelman, and Charles Traynor. Assessment of intelligibility of dysarthric speech. Austin, TX: Pro-ed, 1984.Powell TW. A comparison of English reading passages for elicitation of speech samples from clinical populations. Clin Linguist Phon. 2006;20(2-3):91-7)
Time frame: Intelligibility will be rated offline by blinded listeners who hear the recording 1-12 weeks after speaking tasks are complete.
Rating of microphone likability
Subjects will be asked how well they liked using the microphone on a Likert-type scale of 1-5, from extremely unlikable (1) to extremely likable (5)
Time frame: Immediately after speaking tasks are complete
Rating of speech comprehensibility
Subjects will be asked how well they could understand the speech on a Likert-type scale of 1-5, from not at all understandable (1) to fully understandable (5)
Time frame: Immediately after speaking tasks are complete
Rating of how natural the speech sound quality is
Subjects will be asked how natural the speech sound quality is on a Likert-type scale of 1-5, from not natural (1) to completely natural (5)
Time frame: Immediately after speaking tasks are complete
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Utah