NCT03795753

Determining the Benefits of Improving Communication in BPAP/CPAP Users

Completed NA Results posted Last updated 18 September 2020

What this trial tests

NA trial testing F2S Communicator in Positive-Pressure Respiration in 36 participants. Completed in 8 July 2019.

Timeline

22 March 2019

Primary endpoint
8 July 2019

8 July 2019

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	36
Start date	22 March 2019
Primary completion	8 July 2019
Estimated completion	8 July 2019
Sites	3 locations across United States

Drugs / interventions tested

• F2S Communicator
• Non-functioning Communicator

Conditions studied

• Positive-Pressure Respiration — all drugs for Positive-Pressure Respiration →
• Communication — all drugs for Communication →

Sponsor

Emory University

Who can join

18 and older, any sex, with Positive-Pressure Respiration or Communication. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Accuracy of Single Word Selection (Proportion of Right Words From Total) Primary · Mask on-communicator on-20 minutes

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.

Group	Value	95% CI
F2S Communicator	0.61	± 0.13
Non-functioning Communicator	0.35	± 0.17

Accuracy of Sentence Selection (Proportion of Right Sentences From Total) Primary · Mask on-communicator on-20 minutes

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.

Group	Value	95% CI
F2S Communicator	0.76	± 0.22
Non-functioning Communicator	0.33	± 0.25

Number of Subjects That Found That the Device Significantly Improved Noninvasive Ventilation (NIV) Comfort Secondary · Mask on-communicator on-20 minutes

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.

Group	Value	95% CI
F2S Communicator	11
Non-functioning Communicator	2

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Randomized Controlled Trial of a Novel Communication Device Assessed During Noninvasive Ventilation Therapy.
   Wong AI, Cheung PC, Zhang J, Cotsonis G, et al · · 2021 · cited 7× · PMID 33011202 · DOI 10.1016/j.chest.2020.09.250
2. Consequences and Solutions for the Impact of Communication Impairment on Noninvasive Ventilation Therapy for Acute Respiratory Failure: A Focused Review.
   Wong AI, Cheung PC, Happ MB, Gay PC, et al · · 2020 · cited 5× · PMID 32695990 · DOI 10.1097/cce.0000000000000121