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

NCT ID: NCT04654481

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-20
• Study Completion Date: 2021-10-19

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Standard Care Plus Monitoring

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

Group Type: ACTIVE_COMPARATOR

Standard Care Plus Monitoring

Intervention Type: OTHER

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

Standard Care Plus Monitoring and HCFWO

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.

Group Type: EXPERIMENTAL

HCFWO

Intervention Type: 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.

Standard Care Plus Monitoring

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Standard Care Plus Monitoring

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

Intervention Type: OTHER

Other Intervention Names

High Frequency Chest Wall Oscillation; Afflovest

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Biophysics Corporation

INDUSTRY

Sponsor Role: collaborator

SPARK Healthcare

UNKNOWN

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Patricia Walker

Co-Director, The Cystic Fibrosis Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Walker, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Beth Israel

New York, New York, United States

Countries

United States

Other Identifiers

ISMMS-AFF-20

Identifier Type: OTHER

Identifier Source: secondary_id

GCO 20-2667

Identifier Type: -

Identifier Source: org_study_id