US medical school conducts a study of AffloVest in At-Risk Respiratory Patients During COVID-19 Pandemic
Photo by Brittany Colette
The company Icahn School of Medicine at Mount Sinai is enrolling patients into the clinical trial investigating Study of AffloVest in At-Risk Respiratory Patients During COVID-19 Pandemic.
The purpose of the study is to investigate the addition of high frequency chest wall oscillation (HFCWO) therapy to the prescribed care regimen to support the diaphragm during airway clearance among post-COVID patients with COPD and chronic productive cough as a way to limit the advancement of pulmonary symptoms and need for critical services during recovery from COVID-19.
Thirty study participants in New York City who meet inclusion criteria will be recruited from Mount Sinai's COVID-19 Post-Recovery Center of Excellence and Respiratory Institute. Fifteen subjects (determined by the last digit of their medical record number) will receive a HFCWO device (AffloVest), digital thermometer, pulse oximeter, and spirometer at their home. Participants will be trained remotely to use the AffloVest and spirometer. In addition all subjects will be asked to complete a series of online mental health and respiratory symptom assessments via REDCap.
The aim is to investigate the addition of HFCWO therapy to the prescribed care regimen to support the diaphragm during airway clearance among post-COVID patients with COPD and chronic productive cough as a way to limit the advancement of pulmonary symptoms and need for critical services during recovery from COVID-19.
The study start date is December 2020. The location of the study is Mount Sinai Beth Israel, New York, United States, 10003.
The patients that can be enrolled into this study include:
- Adult males and females ≥18 years
- Existing diagnosis of COPD for >6 months
- Chronic productive cough
- Radiographic evidence of flattening of the diaphragm
- Prior COVID-19 diagnosis
- Clinically followed by Mount Sinai COVID-19 Post Recovery and Respiratory Institute
- Ability to read and fill out survey questionnaires via REDCap (surveys will be available in English and Spanish)
- Access to a home computer, tablet, or smartphone
This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT04654481
