Determining the Benefits of Improving Communication in BPAP/CPAP Users
Phase: NA
Conditions: Positive-Pressure Respiration, Communication
Sponsor: Emory University

 
 
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IRB00097529 
 
NCT03795753 
 
 
Determining the benefits of improving communication in BPAP/CPAP users 
 
Principal Investigator: Nancy A Collop, MD 
 
Date 03/27/2019 
 
 

 
 
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Minimal Risk Protocol  
 
1. Protocol Title 
2. Objectives 
3. Background 
4. Study Design 
5. Study Population 
Number of Subjects 
Inclusion and Exclusion Criteria 
Inclusion 
Exclusion 
Vulnerable Populations 
Setting 
Recruitment Methods 
Consent Process 
6. Procedures 
7. Data and Specimens 
8. Data Analysis 
9. Privacy, Confidentiality and Data Security 
10. Risks and Benefits 
Risks to Subjects 
Adverse events 
Potential Benefits to Subjects 
11. Disclosures 
References 
 
 

 
 
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1. Protocol Title 
Determining the benefits of improving communication in BPAP/CPAP users 
2. Objectives  
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.  
The hypothesis is as follows: The non-invasive communication aid for patients receiving 
BPAP/CPAP therapy will deliver clear and effective communication between the patient and 
medical personnel. Furthermore, the device will increase the patient’s efficacy at communicating 
with others.  
3. Background  
Non-invasive positive pressure ventilation (NIPPV) is a crucial tool used to treat respiratory 
distress and failure, especially in acute exacerbations of COPD. 1 Approximately 15-24 million US 
citizens have COPD. 2,3 Of these patients, acute exacerbations of COPD accounted for almost 
700,000 hospitalizations in 2010, and are expected to increase annually. Exacerbations are 
dangerous - with mortality rates ranging from 2.5% to 28%, depending on severity - and 
expensive - with costs contributing to the $32.1 billion spent annually on COPD. 3,4  
Current medical practice acknowledges that treating respiratory distress and preventing 
respiratory failure is a paramount concern. Given the nature of the NIPPV mask, communication 
impairment is a commonly accepted sacrifice to maintain a patient’s respiratory condition. 
Anecdotally, the history and physical examination of a new patient comprises the majority of the 
data gathering necessary for making medical decisions. Communication is critical to providing 
context.  
However, there is a growing body of work that indicates that limited communication can both 
increase length of stay and readmission rates. We can extrapolate such information from studies 
of communication limitations due to language barriers. For patients with language barriers, a 3-
year retrospective study indicated that the absence of a professional interpreter on just 
admission and discharge alone significantly increased length of stay by 1.5 days and 
readmission rates by 63% (absolute increase 9.4%). 5  
We will therefore study the benefit that improved communication can provide for patients on 

 
 
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NIPPV.  
 
 
 

 
 
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4. Study Design  
This is a single-blinded, randomized control trial.  
The device tested will be referred to as a “communicator”. 
Every patient will be consented. If accepted, we will proceed. Each patient’s partner will also be 
consented. Demographics, including age, race, duration of BPAP/CPAP therapy, will be collected 
at this time.  
Block randomization will be used with variable block sizes of three and six. This guarantees that 
the 2:1 ratio is closely maintained throughout the trial. Sealed envelopes will be utilized, with 
“disable” being the placebo and “enable” being the treatment. The subjects are numbered from 
1 to 42. If we randomize only 30 subjects, we will have 20 enable and 10 disable. If we have 30 
subjects, then the power is 70%.  
One interim analysis will be undertaken after fifteen subjects are evaluated for the primary pre-
post outcome. The O’Brien-Fleming stopping rule will be used with a Type I error rate of 0.05.  
Based upon the randomization envelope, we will randomize patients to the communicator or 
no-communicator arm. The study consenter will turn the device on if randomized to the 

 
 
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communicator and disable the device if randomized to the no-communicator arm. In both 
situations, the device will appear outwardly similar (i.e. power lights will still appear to be on).  
The study will be conducted in three phases:  
 
without the mask on, and 
with the mask on and without the communicator attached, and 
with the mask on and with the communicator attached.  
 
We will recruit patients with both full face mask and nasal mask. 
All patients will be issued a single-use hose and full face mask for the duration of the study. 
Mask fit will be determined by standard templates.  
For all patients for the duration of the trial, we will provide a constant pressure of 10 cm H2O 
when on NIV.  
We may, at our discretion, provide the CPAP/BPAP machine for the duration of the study. 
 
 
 
The study coordinator will first instruct the patient on the study protocols. The patient and the 
partner will be seated a pre-specified distance from each other in a room. The patient and 
partner will be informed that the entire session will be recorded, and the microphone will be 
placed close to the partner. A speaker playing standard ICU background noises at a fixed 
volume will be placed near the patient. 6   
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 
 
Patient 
Partner 
Ambient noise 
speaker 
BPAP/CPAP 
machine 
Microphone 

 
 
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evaluate the “mask off” period.  
The patient will then put on the BPAP/CPAP mask, without the communicator attached.  
Patients will be asked to speak normally with the same volume and effort they used when they 
were speaking without the mask on. Patients will have a trial period where they can read 
through single words and sentences. During this period, a study coordinator may show a sign to 
remind patients that they should not speak louder or overpronounce and overenunciate words.  
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 off” period.  
The communicator will then be attached to the BPAP/CPAP mask. The study coordinator will 
either enable or disable the communicator, based on the randomization arm. A new list of single 
words and 5-word through 15-word sentences will be provided to the patient. The protocol will 
remain the same. 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.  
The audio recording will then be stopped.  
At the end of this period, we will collect the communications devices. The survey collection will 
be optimized by medical record labels affixed to the surveys.  
Audio recordings will be then evaluated by impartial judge(s), again graded for both single word 
and sentence readings. Once the data has been collected, the dataset will then be de-identified 
and stored for further analysis.  
 
5. Study Population 
a) Number of Subjects 
The study intends to include approximately 30 volunteer subjects in a 2:1 assignment, across all 
hospital systems. This study is intended to be held at Grady Memorial Hospital / Emory 
University Hospital / Emory Midtown / Executive Park 12 (Brain Health). 
 
b) Inclusion and Exclusion Criteria 
Inclusion 
Patients must be receiving BPAP/CPAP therapy in the outpatient setting (e.g. clinics, sleep 
centers).  

 
 
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Exclusion 
Patients cannot be intubated or have a tracheostomy.  
No vulnerable populations will be included (children, decisionally impaired adults, and 
prisoners).  
Patients cannot have speech disabilities, or reading disabilities, dyslexia. 
Partners cannot have speech disabilities, hearing disabilities, reading disabilities, or writing 
disabilities. 
English must be their first language. 
 
c) Vulnerable Populations 
1. Children: will be excluded 
2. Pregnant women: will be included given minimal risk 
3. Decisionally impaired adults: will be excluded 
4. Prisoners: will be excluded 
 
d) Setting 
Recruitment, consent process, and equipment administration will be performed by study 
coordinators or study staff at each location.  
Initial data collection will be performed by study staff. Study staff may also participate in blinded 
data evaluation. 
Emory/Grady will not be the coordinating center for any activities.  
All sites will rely on the Emory IRB as a first IRB review. Each location will have their own research 
committee for further review.  
Grady 
We will apply to the Grady research oversight committee.  
Emory Healthcare 
We will apply to Emory research administration. 
 
e) Recruitment Methods 
Patients will be recruited from clinics involved in BPAP/CPAP therapy. Potential subjects will be 
identified by their use of BPAP/CPAP therapy as a form of NIPPV. We will advertise by posting 
signs in clinic rooms and waiting rooms. Additionally, a study staff member may approach 

 
 
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patients waiting in the clinic rooms to inform them about the study. Finally, a study staff 
member may call patients scheduled for upcoming appointments. Subjects (patients, 
family/friends, staff) will be asked to volunteer. We will offer $25.00 to each patient and partner 
in compensation ($50.00 total for each pair) in cash after completion of the full study protocol. 
The price of the communicator will be covered by Ataia, Inc. The devices will remain the 
property of Ataia, Inc. and will not be given to the patients. 
 
f) Consent Process 
Consent will be obtained upon arrival and agreement to participate in the study. Consent will be 
confirmed via the patient’s or partner’s signature on the consent form. The subject will be given 
an explanation of how the device is used and the benefits of participating in the study. The 
patient will be informed that if at any time they revoke consent, to inform the physician, 
respiratory therapist, nurse, or study coordinator.  
6. Procedures 
1. Patient is treated by a sleep specialist with BPAP/CPAP. 
2. Study information and informed consent provided.  
3. If accepted, a study communications device will be attached to the BPAP/CPAP machine. 
a. The standard of care does not have any kind of communications device attached 
to the mask. At the discretion of the clinical staff, communication boards or white 
boards may be provided. 
b. There are two separate arms in this study. The patient will be randomly assigned: 
i. 
to receive a non-functioning study communications device. 
ii. 
to receive a functioning study communications device. 
4. All patients involved in the study will have their medical record number recorded for 
further chart review. 
5. The patient and partner will be briefed by the study coordinator. Patient and partner 
demographics data will be collected at the time of consent.  
6. The patient will meet with study staff to conduct the trial.  
a. Study coordinator will calibrate ambient speaker to desired loudness, as 
measured by decibel meter. Study coordinator will also calibrate other equipment 
for the trial. 
b. Patient and partner will be situated in a standard setting. A microphone will be 
set up adjacent to the partner.  
c. Example words and sentences will be provided to the patient and partner to 
practice protocol. No post-example survey will be provided at this stage. 
d. Words and sentences will be provided to the patient and the partner to learn how 
intelligible the patient is at baseline, without the BPAP/CPAP mask on. The 
patient will read each of the words and sentences - at most twice total - and the 
guest will attempt to either identify or write down what is heard. 
e. A survey will be provided to evaluate the “mask off” stage 

 
 
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f. 
The patient will then wear the BPAP/CPAP mask without the communicator and 
turn on the BPAP/CPAP machine. Patient will be instructed to use their home 
settings.  
g. Patients will be asked to speak normally with the same volume and effort they 
used in the mask off phase. 
h. The partner will subsequently ask the patient to read a new set of trial words and 
sentences, with the partner again trying to identify or write down the spoken 
content. During this period, the study coordinator will show a sign to the patient 
to remind them to avoid overenunciating or overpronouncing words, and to 
avoid raising their voice.  
i. 
The patient will subsequently read a new set of words and sentences, with the 
guest again trying to identify or write down the spoken content. 
j. 
A survey will be provided to evaluate the “mask on, communicator off” stage 
k. The patient will then wear the BPAP/CPAP mask, with the communicator 
attached. 
l. 
The patient will subsequently read a new set of words and sentences, with the 
guest again trying to identify or write down the spoken content. 
m. A survey will be provided to evaluate the “mask on, communicator on” stage 
7. Chart review of the patients. 
8. Study judges blinded to the phase and study arm will transcribe the recorded audio. 
7. Data and Specimens 
Sharing of Results with Subjects 
No lab tests or genetic tests will be performed. Study results will not be shared with subjects or 
their providers. 
8. Data Analysis 
Two-tailed parametric tests will be performed on the de-identified data to compare each arm to 
determine superiority. The primary goal of this study is to determine effect size and observe 
device usage.  
Likert scales will be compared across patients and partners using a nonparametric test. 
Randomization 
Block randomization will be used with variable block sizes of three and isx. This guarantees that 
the 2:1 ratio is closely maintained througout the trial. Sealed envelopes will be utilized, with 
“disable” being the placebo and “enable” being the treatment. The subjects are numbered from 
1 to 42. If we randomize only 30 subjects, we will have 20 enable and 10 disable. If we have 30 
subjects, then the power is 70%. 
Interim analysis 
One interim analysis will be undertaken after fifteen subjects are evaluated for the primary pre-

 
 
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post outcome. The O’Brien-Fleming stopping rule will be used with a Type I error rate of 0.05.  
9. Privacy, Confidentiality and Data Security 
All subjects will be assigned a study ID. Subject forms will be organized with medical record 
stickers for ease of use. Data collation and chart review will then be performed by authorized 
personnel.  
During chart review, we will gather relevant clinical history, including but not limited to previous 
diagnoses (especially COPD or asthma), duration of BPAP/CPAP therapy, and any factors that 
may impair patient communication. Additionally, incidental relevant possible or probable 
complications will be recorded.  
Once data collation and chart review has been completed, the data shall be de-identified and 
referred for statistical analysis. 
All data will be encrypted, regardless of identified or de-identified. Certificates of confidentiality 
and other paperwork shall be stored in a secured location by authorized personnel.  
 
10. Risks and Benefits 
a. Risks to Subjects 
This study involves a new device that assists in communication for patients requiring 
BPAP/CPAP, and does not disrupt the function of the BPAP/CPAP. The device will not be in 
direct contact with the patient. Based on its design, it is unlikely to interrupt BPAP/CPAP 
functionality. There are no additional lab tests or imaging that should be required to participate 
in this study. There may be other risks, discomforts, and side effects that are not yet known. 
 
It is unlikely that a survey will pose any risk. It is further unlikely that recorded audio of provided 
words and sentences will pose any risk.  
 
Chart review will be performed by approved personnel to further quantify side effects. Reviewed 
data will be de-identified prior to further analysis.  
 
We will provide a mask and hose to the patient for the duration of this trial. It is unlikely that a 
standard single-use CPAP/BPAP mask will pose any risk for the duration of the trial. 
 
For the duration of the trial, we will provide a constant pressure of 10 cm H2O when on NIV.  It 
is unlikely that this pressure will pose any risk for the duration of the trial.  
 
The patch, designed to adhere to the mask, is also designed to be completely removable within 
the first 8 hours after application. We will be able to remove any unwanted adhesive residue. In 

 
 
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the event that the patient’s mask is unable to function in the original condition once the patch is 
removed, as per determined by the study staff, we will be able to replace the mask.  
 
 
 
i. 
Adverse events 
In the event that an adverse event occurs, the study staff conducting the experiment will record 
the circumstances. These forms will be submitted to the co-investigator and/or PI for review. 
Adverse event forms will be reviewed weekly.  
 
These forms will also be sent to the Ataia Medical Quality officer.  
 
 
 
 
b. Potential Benefits to Subjects 
Taking part in this research may, if on the intervention arm, potentially benefit the patient and 
those interacting with the patient by facilitating communication. If assigned to the control arm 
of the study, there may be no direct benefit to the patient from taking part in this study. 
However, this research study may help us learn new things that may help patients in the future.  
 
11. Disclosures 
 
Dr. Wong has developed IP that has been released to Ataia Medical, a company interested in 
further developing the IP that is the subject of this publication. Dr. Wong serves as Chief Medical 
Officer and has ownership interests in Ataia Medical. The terms of this arrangement have been 
reviewed and approved by Emory University in accordance with its conflict of interest policies. 
 
 
 

 
 
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References 
 
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Confalonieri, M. et al. Noninvasive mechanical ventilation improves the immediate 
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Centers for Disease Control and Prevention (CDC). Chronic obstructive pulmonary 
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3. 
Perera, P. N., Armstrong, E. P., Sherrill, D. L. & Skrepnek, G. H. Acute exacerbations 
of COPD in the United States: inpatient burden and predictors of costs and 
mortality. COPD 9, 131–141 (2012). 
4. 
Ford, E. S. et al. Total and state-specific medical and absenteeism costs of COPD 
among adults aged ≥ 18 years in the United States for 2010 and projections 
through 2020. Chest 147, 31–45 (2015). 
5. 
Lindholm, M., Hargraves, J. L., Ferguson, W. J. & Reed, G. Professional language 
interpretation and inpatient length of stay and readmission rates. J. Gen. Intern. 
Med. 27, 1294–1299 (2012). 
6. 
Busch-Vishniac, I. J. et al. Noise levels in Johns Hopkins Hospital. J. Acoust. Soc. Am. 
118, 3629–3645 (2005).