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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03795753
Other study ID # IRB00097529
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 22, 2019
Est. completion date July 8, 2019

Study information

Verified date August 2020
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date July 8, 2019
Est. primary completion date July 8, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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:
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.

Locations

Country Name City State
United States Emory Clinic Atlanta Georgia
United States Emory University Hospital Atlanta Georgia
United States Grady Health System Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. Mask on-communicator on-20 minutes
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. Mask on-communicator on-20 minutes
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. Mask on with communicator on (20 min)
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. Mask on-communicator on-20 minutes
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