N/A
N=36
Determining the Benefits of Improving Communication in BPAP/CPAP Users
Positive-Pressure Respiration · Communication
Bottom Line
View on ClinicalTrials.gov: NCT03795753 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Accuracy of Single Word Selection (Proportion of Right Words From Total) — 0.61; 0.35 proportion of right words
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- F2S Communicator (Device); Non-functioning Communicator (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Single Word Selection (Proportion of Right Words From Total) |
0.61; 0.35 | — |
| PRIMARY Accuracy of Sentence Selection (Proportion of Right Sentences From Total) |
0.76; 0.33 | — |
| SECONDARY Speech Transmission Index (STI) |
— | — |
| SECONDARY Number of Subjects That Found That the Device Significantly Improved Noninvasive Ventilation (NIV) Comfort |
11; 2 | — |
Summary
The purpose of this study is to determine the effectiveness of a non-invasive communication aid for BPAP/CPAP masks. This study also looks to determine the potential impact of the device on patients with obstructive sleep apnea (OSA) and the individuals that interact with the device.
Eligibility Criteria
Inclusion Criteria
- Patients must be receiving BPAP/CPAP therapy in the outpatient setting (e.g. clinics, sleep centers).
Exclusion Criteria
- Intubated or have a tracheostomy.
- Vulnerable populations (children, pregnant women, decisionally impaired adults, and prisoners).
- Speech disabilities, reading disabilities, dyslexia.
Data sourced from ClinicalTrials.gov (NCT03795753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.