Determining the Benefits of Improving Communication in BPAP/CPAP Users
1 other identifier
interventional
36
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2018
CompletedFirst Posted
Study publicly available on registry
January 8, 2019
CompletedStudy Start
First participant enrolled
March 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2019
CompletedResults Posted
Study results publicly available
September 18, 2020
CompletedSeptember 18, 2020
August 1, 2020
4 months
December 28, 2018
June 25, 2020
August 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Speech Transmission Index (STI)
Mask on with communicator on (20 min)
Number of Subjects That Found That the Device Significantly Improved Noninvasive Ventilation (NIV) Comfort
Mask on-communicator on-20 minutes
Study Arms (2)
F2S Communicator
EXPERIMENTALThe 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.
Non-functioning Communicator
SHAM COMPARATORNon-functioning study communication device is used.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients must be receiving BPAP/CPAP therapy in the outpatient setting (e.g. clinics, sleep centers).
You may not qualify if:
- Intubated or have a tracheostomy.
- Vulnerable populations (children, pregnant women, decisionally impaired adults, and prisoners).
- Speech disabilities, reading disabilities, dyslexia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (3)
Emory Clinic
Atlanta, Georgia, 30322, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Grady Health System
Atlanta, Georgia, 30322, United States
Related Publications (1)
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.
PMID: 33011202DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Nancy Collop
- Organization
- Emory University
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy Collop, MD
Emory University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 28, 2018
First Posted
January 8, 2019
Study Start
March 22, 2019
Primary Completion
July 8, 2019
Study Completion
July 8, 2019
Last Updated
September 18, 2020
Results First Posted
September 18, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share