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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43HL147788-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| Axon Medical, Inc. | UNKNOWN |
| Intermountain Health Care, Inc. | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) |
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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 ReddyPortâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Patient talking with microphone first turned on and then off |
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| Arm 2 | Experimental | Patient talking with microphone first turned off and then on |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninvasive Ventilation Mask Microphone | Device | Noninvasive Ventilation Mask Microphone is turned on to enhance speech intelligibility during the intervention portion of the crossover feasibility study |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Intelligibility will be rated offline by blinded listeners who hear the recording 1-12 weeks after speaking tasks are complete. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Immediately after speaking tasks are complete |
| Rating of speech comprehensibility |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lara Brewer, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
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| ID | Term |
|---|---|
| D013065 | Speech Intelligibility |
| ID | Term |
|---|---|
| D013060 | Speech |
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |
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| NIH |
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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) |
| 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) | Immediately after speaking tasks are complete |