Determining the Benefits of Improving Communication in BPAP/CPAP Users

Communication Clinical Trial

Official title:

Determining the Benefits of Improving Communication in BPAP/CPAP Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03795753
• Other study ID #: IRB00097529
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Communication
• Positive-Pressure Respiration

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