CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
F2S Communicator +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03795753
NCT03795753N/ACompleted

Determining the Benefits of Improving Communication in BPAP/CPAP Users

Emory University·interventional·Posted Jan 8, 2019·Updated Sep 18, 2020

In Brief

A clinical study evaluating F2S Communicator and Non-functioning Communicator for Positive-Pressure Respiration and Communication. Completed, enrolled 36 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 8, 2019
Enrollment StartMar 22, 2019
Primary CompletionJul 8, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.5 years ago

Interventions

F2S Communicatordevice

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.

Non-functioning Communicatorother

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.