NCT04654481

Study of AffloVest in At-Risk Respiratory Patients During COVID-19 Pandemic

Feasibility of Using a Home-Based High Frequency Chest Wall Oscillation Device (AffloVest) in At-Risk Respiratory Patients to Decrease Acute Respiratory Care Burden During the COVID-19 Pandemic

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. A 15 patient control group meeting inclusion criteria will be recruited from the Mount Sinai COVID-19 Post-Recovery Center of Excellence and Respiratory Institute using the same screening process. This group will not receive the HFCWO intervention but will receive a digital thermometer, pulse oximeter, and spirometer at their home (with training via telehealth), asked to complete all REDCap and respiratory symptom assessments. Consent for both groups will be obtained by a Mount Sinai clinician-researcher. Study Duration Approximately 30 days plus 60 and 90-day check in Objectives 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.

Conditions

• Chronic Obstructive Pulmonary Disease
• Chronic Cough
• Covid19

Interventions

Type	Name	Description
DEVICE	HCFWO	The Afflovest device is a High Frequency Chest Wall Oscillation (HFCWO) device, a medical vest that uses vibrations to loosen and mobilize mucus in the lung secretions and help clear the airways.
OTHER	Standard Care Plus Monitoring	Monitoring via home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments.

Timeline

• Start date: 2021-07-20
• Primary completion: 2021-10-19
• Completion: 2021-10-19
• First posted: 2020-12-04
• Last updated: 2022-05-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study