Communication Clinical Trial
Official title:
Determining the Benefits of Improving Communication in BPAP/CPAP Users
NCT number | NCT03795753 |
Other study ID # | IRB00097529 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 22, 2019 |
Est. completion date | July 8, 2019 |
Verified date | August 2020 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | July 8, 2019 |
Est. primary completion date | July 8, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Emory Clinic | Atlanta | Georgia |
United States | Emory University Hospital | Atlanta | Georgia |
United States | Grady Health System | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of Single Word Selection (Proportion of Right Words From Total) | Data will be collected using audio recording - accuracy of single word selection (spoken by patient -> selected by partner). The communicator will be attached to the BPAP/CPAP mask. A list of single words will be provided to the patient. Each single word may be read aloud by patient up to two times. The partner must then select the read word out of a list of twelve possible words. | Mask on-communicator on-20 minutes | |
Primary | Accuracy of Sentence Selection (Proportion of Right Sentences From Total) | Data will be collected using audio recording - accuracy of sentence selection (spoken by patient -> transcribed by partner). The communicator will be attached to the BPAP/CPAP mask. A list of 5-word through 15-word sentences will be provided to the patient. Each sentence may be read aloud by patient up to two times. The partner must transcribe each sentence on a standardized form. | Mask on-communicator on-20 minutes | |
Secondary | Speech Transmission Index (STI) | STI is a numeric representation measure of communication channel characteristics whose value varies from 0 = bad to 1 = excellent.On this scale, an STI of at least 0.5 is desirable for most applications. | Mask on with communicator on (20 min) | |
Secondary | Number of Subjects That Found That the Device Significantly Improved Noninvasive Ventilation (NIV) Comfort | Number of subjects that found that the device significantly improved noninvasive ventilation (NIV) comfort was calculated and reported. Assessment of noninvasive ventilation (NIV) comfort was conducted using Likert Scale Score on clarity of communication on a symmetric seven-level agree-disagree scale. | Mask on-communicator on-20 minutes |
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