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

Last updated: April 29, 2022
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Terminated

Phase

N/A

Condition

Covid-19

Chronic Cough

Treatment

N/A

Clinical Study ID

NCT04654481
GCO 20-2667
ISMMS-AFF-20
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 provide informed consent
  • Ability to read and fill out survey questionnaires via REDCap (surveys will beavailable in English and Spanish)
  • Access to a home computer, tablet, or smartphone

Exclusion

Exclusion Criteria:

  • Presenting with hypoxia (02 sat <90%)
  • Acute COVID-19 infection
  • Home oxygen dependent
  • Established diagnosis of cystic fibrosis
  • History of osteoporosis or rib fracture
  • Active Hemoptysis
  • Pneumothorax

Study Design

Total Participants: 1
Study Start date:
July 20, 2021
Estimated Completion Date:
October 19, 2021

Study 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.

Connect with a study center

  • Mount Sinai Beth Israel

    New York, New York 10003
    United States

    Site Not Available

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