NCT04912544

Facilitating Patient Communication During Noninvasive Ventilation

Feasibility and Intelligibility Testing of a Microphone System to Facilitate Patient Communication During Noninvasive Ventilation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Noninvasive Ventilation
• Speech Intelligibility

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-10-11
• Primary completion: 2022-04-15
• Completion: 2022-05-09
• First posted: 2021-06-03
• Last updated: 2022-08-01

Locations

1 site across 1 country: United States