Trial Outcomes & Findings for Determining the Benefits of Improving Communication in BPAP/CPAP Users (NCT NCT03795753)

Last Updated: 2020-09-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

Mask on-communicator on-20 minutes

Results posted on

2020-09-18

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.	Non-functioning Communicator Non-functioning study communication device is used. 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.
Overall Study STARTED	23	13
Overall Study COMPLETED	23	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Determining the Benefits of Improving Communication in BPAP/CPAP Users

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	F2S Communicator n=23 Participants 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. 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.	Non-functioning Communicator n=13 Participants Non-functioning study communication device is used. 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.	Total n=36 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 13.3 • n=5 Participants	59.9 years STANDARD_DEVIATION 17.1 • n=7 Participants	57.03 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	4 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	13 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Mask on-communicator on-20 minutes

Outcome measures

Outcome measures
Measure	F2S Communicator n=23 Participants 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. 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.	Non-functioning Communicator n=13 Participants Non-functioning study communication device is used. 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.
Accuracy of Single Word Selection (Proportion of Right Words From Total)	0.61 proportion of right words Standard Deviation 0.13	0.35 proportion of right words Standard Deviation 0.17

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	F2S Communicator n=23 Participants 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. 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.	Non-functioning Communicator n=13 Participants Non-functioning study communication device is used. 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.
Accuracy of Sentence Selection (Proportion of Right Sentences From Total)	0.76 proportion of sentence intelligibility Standard Deviation 0.22	0.33 proportion of sentence intelligibility Standard Deviation 0.25

SECONDARY outcome

Timeframe: Mask on with communicator on (20 min)

Population: A validated conversion for word/sentence accuracy and STI was not predetermined and the intent was to record at both the mask and the speaker. However, the conversion was not able to be determined and recording at the mask level was limited by the device. Thus, there is no effective comparator to calculate STI and this information is unavailable.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	F2S Communicator n=23 Participants 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. 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.	Non-functioning Communicator n=13 Participants Non-functioning study communication device is used. 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.
Number of Subjects That Found That the Device Significantly Improved Noninvasive Ventilation (NIV) Comfort	11 Participants	2 Participants

Adverse Events

F2S Communicator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-functioning Communicator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nancy Collop

Emory University

Phone: 404-712-7533

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place