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

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.

• HCFWO (Device), also known as High Frequency Chest Wall Oscillation, Afflovest: 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 (Other): Monitoring via home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments.

Primary outcomes

• Change in forced expiratory volume in one second (FEV1) [Baseline and up to 90 Days]: Change in forced expiratory volume in one second (FEV1) as compared to baseline, measured by home spirometer.
• Change in Oxygen Saturation level [Baseline and up to 90 Days]: 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.
• Change in Presence of Fever [Baseline and up to 90 Days]: Changes in basal temperature as measured by digital thermometer. Fever is indicated at 100.4 F (38 C) or higher.

Secondary outcomes

• Change in Presence of pneumonia symptoms via Community Acquired Pneumonia (CAP) Symptom Questionnaire [Baseline and up to 90 Days]: 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.
• Change in Quality of life via Quality of Life Questionnaire-Respiratory (QOL-B) [Baseline and up to 90 Days]: 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.
• Change in Mental health screening via Personal Health Questionnaire Depression Scale (PHQ-8) [Baseline and up to 90 Days]: 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.
• Change in Mental health screening via General Anxiety Disorder-7 (GAD-7) [Baseline and up to 90 Days]: 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.
• Change in COVID Symptom Checklist [Baseline and up to 90 Days]: 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.
• AffloVest Usage [90 Days]: Amount of time used per week in minutes

Sex: All, ages: 18 Years to any

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

• Patricia Walker, MD, Principal investigator, Icahn School of Medicine at Mount Sinai