Determining the Benefits of Improving Communication in BPAP/CPAP Users

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.

Study Overview

• Status: Completed
• Conditions: Communication; Positive-Pressure Respiration
• Intervention / Treatment: Device: F2S Communicator; Other: Non-functioning Communicator

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30322
      • Emory Clinic
    • Atlanta, Georgia, United States, 30322
      • Grady Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: F2S Communicator; 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.; Other Names: BPAP/CPAP communicator
SHAM_COMPARATOR: Non-functioning Communicator; Non-functioning study communication device is used.	Other: Non-functioning Communicator; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Nancy Collop, MD, Emory University

Publications and helpful links

General Publications

• Wong AI, Cheung PC, Zhang J, Cotsonis G, Kutner M, Gay PC, Collop NA. Randomized Controlled Trial of a Novel Communication Device Assessed During Noninvasive Ventilation Therapy. Chest. 2021 Apr;159(4):1531-1539. doi: 10.1016/j.chest.2020.09.250. Epub 2020 Oct 1.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 22, 2019
• Primary Completion (ACTUAL): July 8, 2019
• Study Completion (ACTUAL): July 8, 2019

Study Registration Dates

• First Submitted: December 28, 2018
• First Submitted That Met QC Criteria: January 4, 2019
• First Posted (ACTUAL): January 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; Chronic obstructive pulmonary disease; Emphysema
• Other Study ID Numbers: IRB00097529

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No