Determining the Benefits of Improving Communication in BPAP/CPAP Users

Study Overview
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Brief Summary
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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
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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.

Official Title
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Determining the Benefits of Improving Communication in BPAP/CPAP Users

Conditions
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Positive-Pressure Respiration, Communication

Intervention / Treatment
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* Device: F2S Communicator
* Other: Non-functioning Communicator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F2S Communicator<br>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. | Device: F2S Communicator<br>* The communicator will be attached to the BPAP/CPAP mask. The study coordinator will ENABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the mask on, communicator on period.<br>* Other names: BPAP/CPAP communicator;|
| Sham Comparator: Non-functioning Communicator<br>Non-functioning study communication device is used. | Other: Non-functioning Communicator<br>* The communicator will be attached to the BPAP/CPAP mask. The study coordinator will DISABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the mask on, communicator on period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emphysema, Chronic obstructive pulmonary disease, Obstructive sleep apnea