Determining the Benefits of Improving Communication in BPAP/CPAP Users

Not Applicable

Completed

Brief 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.

Detailed Description: Noninvasive positive pressure ventilation (NIPPV) is a crucial tool used to treat respiratory distress and failure, especially when patients have acute worsening (also called exacerbations) of emphysema or chronic obstructive pulmonary disease (COPD). This study will randomize patients who use Noninvasive positive pressure ventilation (NIPPV) to a control (non-functioning) and intervention (functioning) device to determine how well speech can be understood while wearing the device.

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.

Recruitment & 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.

Arm && Interventions

Group	Intervention	Description
F2S Communicator	F2S Communicator	The F2S Communication System is a communication aid for use with a noninvasive ventilation (NIV) mask covering at least the mouth. It is a two-component system consisting of (1) a disposable, single patient use patch and signal cable and (2) a reusable communicator with power cable.The non-invasive aid for patients receiving BPAP/CPAP therapy delivers communication between the patient and medical personnel.
Non-functioning Communicator	Non-functioning Communicator	Non-functioning study communication device is used.

Primary Outcome Measures

Name	Time	Method
Accuracy of Single Word Selection (Proportion of Right Words From Total)	Mask on-communicator on-20 minutes	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.
Accuracy of Sentence Selection (Proportion of Right Sentences From Total)	Mask on-communicator on-20 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Speech Transmission Index (STI)	Mask on with communicator on (20 min)	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.
Number of Subjects That Found That the Device Significantly Improved Noninvasive Ventilation (NIV) Comfort	Mask on-communicator on-20 minutes	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.

Locations (3): Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
Grady Health System
🇺🇸
Atlanta, Georgia, United States
Emory Clinic
🇺🇸
Atlanta, Georgia, United States