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

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.

Study Overview

• Status: Terminated
• Conditions: Covid19; Chronic Obstructive Pulmonary Disease; Chronic Cough
• Intervention / Treatment: Other: Standard Care Plus Monitoring; Device: HCFWO

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Mount Sinai Beth Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard Care Plus Monitoring; 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; Monitoring via home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments.
EXPERIMENTAL: 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.	Other: Standard Care Plus Monitoring; Monitoring via home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments.; 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 Names: High Frequency Chest Wall Oscillation; Afflovest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Presence of pneumonia symptoms via Community Acquired Pneumonia (CAP) Symptom Questionnaire	CAP Symptom Questionnaire records how much the patient rated the bothersomeness of the symptom. Each item is scored as "0" (Patient did not have this symptom), "1" (Not at All) to "5" (Extremely). Full range scale from 0 to 90, higher score indicating patient experiencing more frequent or more severe symptoms.	Baseline and up to 90 Days
Change in Quality of life via Quality of Life Questionnaire-Respiratory (QOL-B)	The QOL-B is a disease-specific questionnaire that measures symptoms, functioning, and health-related quality of life relevant to patients with bronchiectasis. Scores are generated from 37 items that fall on 8 domains: Physical Functioning, Role Functioning, Vitality, Emotional Functioning, Social Functioning, Treatment Burden, Health Perceptions, and Respiratory Symptoms. All subscales and the full range scale are standardized to score from 0 to 100, with higher scores indicating better enjoyment and satisfaction with specific life domains.	Baseline and up to 90 Days
Change in Mental health screening via Personal Health Questionnaire Depression Scale (PHQ-8)	The PHQ-8 is the depression module, which scores each of the eight DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Full scale from 0-24, with higher score indicating more severe symptoms.	Baseline and up to 90 Days
Change in Mental health screening via General Anxiety Disorder-7 (GAD-7)	The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire that asks user to rank how often they have been bothered by seven problems over the past two weeks from "0" (not at all) to "3" (nearly every day). Full scale from 0-21, with higher score indicating more symptoms.	Baseline and up to 90 Days
Change in COVID Symptom Checklist	Eight questions that are specific to recent literature describing patients' experiences of symptoms during COVID. They are rated on a frequency scale from "never" to "always," using a 1-4 point scale. Full scale range from 8 to 32, with higher scores indicating more frequent symptoms.	Baseline and up to 90 Days
AffloVest Usage	Amount of time used per week in minutes	90 Days

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: International Biophysics Corporation; SPARK Healthcare
• Investigators: Principal Investigator: Patricia Walker, MD, ICAHN School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2021
• Primary Completion (ACTUAL): October 19, 2021
• Study Completion (ACTUAL): October 19, 2021

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (ACTUAL): December 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Pulmonary Disease; High Frequency Chest Wall Oscillation; Airway Clearance Therapy
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; COVID-19; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: GCO 20-2667; ISMMS-AFF-20 (OTHER: International Biophysics, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes