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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04912544
Study type Interventional
Source University of Utah
Contact
Status Completed
Phase N/A
Start date October 11, 2021
Completion date May 9, 2022

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