Determining the Benefits of Improving Communication in BPAP/CPAP Users

Emory University

Status: Completed

Conditions: Positive-Pressure Respiration; Communication

Treatments: Other: Non-functioning Communicator; Device: F2S Communicator

Study type: Interventional

Funder types: Other

Identifiers

NCT03795753

IRB00097529

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

F2S Communicator

Experimental group

Description:

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.

Treatment:

Device: F2S Communicator

Non-functioning Communicator

Sham Comparator group

Description:

Non-functioning study communication device is used.

Treatment:

Other: Non-functioning Communicator