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Determining the Benefits of Improving Communication in BPAP/CPAP Users

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ClinicalTrials.gov Identifier: NCT03795753
Recruitment Status : Completed
First Posted : January 8, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Nancy Abbey Collop, MD, Emory University

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.

Condition or disease Intervention/treatment Phase
Positive-Pressure Respiration Communication Device: F2S Communicator Other: Non-functioning Communicator Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determining the Benefits of Improving Communication in BPAP/CPAP Users
Actual Study Start Date : March 22, 2019
Actual Primary Completion Date : July 8, 2019
Actual Study Completion Date : July 8, 2019

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 Name: 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.




Primary Outcome Measures :
  1. Change in accuracy of single word selection (Number right/ Number total) [ Time Frame: Mask off (20 min), mask on with communicator off (20 min) [as compared to mask off], mask on with communicator on (20 min) [as compared to mask off and mask on communicator off] ]
    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.

  2. Change in accuracy of sentence selection (Number right/ Number total) [ Time Frame: Mask off (20 min), mask on with communicator off (20 min) [as compared to mask off], mask on with communicator on (20 min) [as compared to mask off and mask on communicator off] ]
    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 Outcome Measures :
  1. Speech transmission index (STI) [ Time Frame: 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.

  2. Likert Scale Score on clarity of communication [ Time Frame: Mask off (20 min), mask on with communicator off (20 min) [as compared to mask off], mask on with communicator on (20 min) [as compared to mask off and mask on communicator off] ]
    Respondents will specify their level of agreement or disagreement on a symmetric seven-level agree-disagree scale for the following statements: 1) I can communicate with my partner clearly; 2)I felt understood when I read single words; 3) I felt understood when I read short (5-9 word) sentences; 4) I felt understood when I read long (10-15 word) sentences. The scale range captures the intensity form "strongly disagree" to "strongly agree".After the questionnaire is completed, responses will be summed to create a score.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795753


Locations
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United States, Georgia
Emory Clinic
Atlanta, Georgia, United States, 30322
Emory University Hospital
Atlanta, Georgia, United States, 30322
Grady Health System
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Nancy Collop, MD Emory University

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Responsible Party: Nancy Abbey Collop, MD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT03795753     History of Changes
Other Study ID Numbers: IRB00097529
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Nancy Abbey Collop, MD, Emory University:
Emphysema
Chronic obstructive pulmonary disease
Obstructive sleep apnea