Clinical trial NCT03795753: Determining the Benefits of Improving Communication in BPAP/CPAP Users
Official title: Determining the Benefits of Improving Communication in BPAP/CPAP Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Positive-Pressure Respiration
Communication
Keywords: Emphysema
Chronic obstructive pulmonary disease
Obstructive sleep apnea
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Accuracy of Single Word Selection (Proportion of Right Words From Total)
timeFrame: Mask on-communicator on-20 minutes
measure: Accuracy of Sentence Selection (Proportion of Right Sentences From Total)
timeFrame: Mask on-communicator on-20 minutes
Secondary outcomes:
measure: Speech Transmission Index (STI)
timeFrame: Mask on with communicator on (20 min)
measure: Number of Subjects That Found That the Device Significantly Improved Noninvasive Ventilation (NIV) Comfort
timeFrame: Mask on-communicator on-20 minutes
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
Study officials:
affiliation: Emory University
name: Nancy Collop, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong AI, Cheung PC, Zhang J, Cotsonis G, Kutner M, Gay PC, Collop NA. Randomized Controlled Trial of a Novel Communication Device Assessed During Noninvasive Ventilation Therapy. Chest. 2021 Apr;159(4):1531-1539. doi: 10.1016/j.chest.2020.09.250. Epub 2020 Oct 1.