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

NCT04654481 | Terminated FDA Device

• 2 other identifiers: GCO 20-2667ISMMS-AFF-20
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; Chronic Cough; Covid19

Keywords

Pulmonary Disease; Airway Clearance Therapy; High Frequency Chest Wall Oscillation

Outcome Measures

Primary Outcomes (3)

• Change in forced expiratory volume in one second (FEV1)

  Change in forced expiratory volume in one second (FEV1) as compared to baseline, measured by home spirometer.

  Baseline and up to 90 Days

• Change in Oxygen Saturation level

  Changes in oxygen saturation from baseline as measured by pulse oximeter. Normal oxygen range is 95 to 100 percent and low oxygen range is under 90 percent.

  Baseline and up to 90 Days

• Change in Presence of Fever

  Changes in basal temperature as measured by digital thermometer. Fever is indicated at 100.4 F (38 C) or higher.

  Baseline and up to 90 Days

Secondary Outcomes (6)

• Change in Presence of pneumonia symptoms via Community Acquired Pneumonia (CAP) Symptom Questionnaire

  Baseline and up to 90 Days

• Change in Quality of life via Quality of Life Questionnaire-Respiratory (QOL-B)

  Baseline and up to 90 Days

• Change in Mental health screening via Personal Health Questionnaire Depression Scale (PHQ-8)

  Baseline and up to 90 Days

• Change in Mental health screening via General Anxiety Disorder-7 (GAD-7)

  Baseline and up to 90 Days

• Change in COVID Symptom Checklist

  Baseline and up to 90 Days

Study Arms (2)

Standard Care Plus Monitoring

ACTIVE COMPARATOR

All subjects will be monitored via home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments.

Other: Standard Care Plus Monitoring

Standard Care Plus Monitoring and HCFWO

EXPERIMENTAL

In addition to home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments, subject will receive an Afflovest device for home use.

Device: HCFWO; Other: Standard Care Plus Monitoring

Interventions

HCFWO DEVICE

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.

Also known as: High Frequency Chest Wall Oscillation, Afflovest

Standard Care Plus Monitoring and HCFWO

Standard Care Plus Monitoring OTHER

Monitoring via home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments.

Standard Care Plus Monitoring; Standard Care Plus Monitoring and HCFWO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 be available in English and Spanish)
• Access to a home computer, tablet, or smartphone

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• International Biophysics Corporation: collaborator
• SPARK Healthcare: collaborator

Study Sites (1)

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Chronic Cough; COVID-19; Lung Diseases

Interventions

Chest Wall Oscillation; Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cough; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Patricia Walker, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician and data analysts will be blinded to treatment cohort.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, The Cystic Fibrosis Center

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 4, 2020
• Study Start: July 20, 2021
• Primary Completion: October 19, 2021
• Study Completion: October 19, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)