N/A Completed N=36 Randomized Single-blind Treatment

Determining the Benefits of Improving Communication in BPAP/CPAP Users

Positive-Pressure Respiration · Communication

Source: ClinicalTrials.gov NCT03795753 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcomePrimary: Accuracy of Single Word Selection (Proportion of Right Words From Total) — 0.61; 0.35 proportion of right words

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Accuracy of Single Word Selection (Proportion of Right Words From Total)	0.61; 0.35	—
PRIMARY Accuracy of Sentence Selection (Proportion of Right Sentences From Total)	0.76; 0.33	—
SECONDARY Speech Transmission Index (STI)	—	—
SECONDARY Number of Subjects That Found That the Device Significantly Improved Noninvasive Ventilation (NIV) Comfort	11; 2	—

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03795753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.