Communication, Positive-Pressure Respiration
Conditions
Keywords
Emphysema, Chronic obstructive pulmonary disease, Obstructive sleep apnea
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.
Interventions
DEVICEF2S 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.
OTHERNon-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.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Single Word Selection (Proportion of Right Words From Total) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Speech Transmission Index (STI) | Mask on with communicator on (20 min) | 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. |
| Number of Subjects That Found That the Device Significantly Improved Noninvasive Ventilation (NIV) Comfort | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| 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. | 13 |
| Total | 36 |
Baseline characteristics
| Characteristic | F2S Communicator | Total | Non-functioning Communicator |
|---|---|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 13.3 | 57.03 years STANDARD_DEVIATION 14.7 | 59.9 years STANDARD_DEVIATION 17.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 17 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 19 Participants | 9 Participants |
| Region of Enrollment United States | 23 participants | 36 participants | 13 participants |
| Sex: Female, Male Female | 13 Participants | 19 Participants | 6 Participants |
| Sex: Female, Male Male | 10 Participants | 17 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 13 |
| other Total, other adverse events | 0 / 23 | 0 / 13 |
| serious Total, serious adverse events | 0 / 23 | 0 / 13 |
Outcome results
Primary
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.
Time frame: Mask on-communicator on-20 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F2S Communicator | Accuracy of Sentence Selection (Proportion of Right Sentences From Total) | 0.76 proportion of sentence intelligibility | Standard Deviation 0.22 |
| Non-functioning Communicator | Accuracy of Sentence Selection (Proportion of Right Sentences From Total) | 0.33 proportion of sentence intelligibility | Standard Deviation 0.25 |
Primary
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.
Time frame: Mask on-communicator on-20 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F2S Communicator | Accuracy of Single Word Selection (Proportion of Right Words From Total) | 0.61 proportion of right words | Standard Deviation 0.13 |
| Non-functioning Communicator | Accuracy of Single Word Selection (Proportion of Right Words From Total) | 0.35 proportion of right words | Standard Deviation 0.17 |
Secondary
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.
Time frame: Mask on-communicator on-20 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| F2S Communicator | Number of Subjects That Found That the Device Significantly Improved Noninvasive Ventilation (NIV) Comfort | 11 Participants |
| Non-functioning Communicator | Number of Subjects That Found That the Device Significantly Improved Noninvasive Ventilation (NIV) Comfort | 2 Participants |
Secondary
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.
Time frame: 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.