Determining the Benefits of Improving Communication in BPAP/CPAP Users
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Positive-Pressure Respiration
- Sponsor
- Emory University
- Enrollment
- 36
- Locations
- 3
- Primary Endpoint
- Accuracy of Single Word Selection (Proportion of Right Words From Total)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Nancy Abbey Collop, MD
Professor
Emory University
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.
Outcomes
Primary Outcomes
Accuracy of Single Word Selection (Proportion of Right Words From Total)
Time Frame: 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)
Time Frame: 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 Outcomes
- Speech Transmission Index (STI)(Mask on with communicator on (20 min))
- Number of Subjects That Found That the Device Significantly Improved Noninvasive Ventilation (NIV) Comfort(Mask on-communicator on-20 minutes)