Clinical trial NCT04654481: Study of AffloVest in At-Risk Respiratory Patients During COVID-19 Pandemic
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Chronic Cough
Covid19
Keywords: Pulmonary Disease
Airway Clearance Therapy
High Frequency Chest Wall Oscillation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: International Biophysics Corporation
name: SPARK Healthcare
First posted: 2020-12-04
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in forced expiratory volume in one second (FEV1)
timeFrame: Baseline and up to 90 Days
measure: Change in Oxygen Saturation level
timeFrame: Baseline and up to 90 Days
measure: Change in Presence of Fever
timeFrame: Baseline and up to 90 Days
Secondary outcomes:
measure: Change in Presence of pneumonia symptoms via Community Acquired Pneumonia (CAP) Symptom Questionnaire
timeFrame: Baseline and up to 90 Days
measure: Change in Quality of life via Quality of Life Questionnaire-Respiratory (QOL-B)
timeFrame: Baseline and up to 90 Days
measure: Change in Mental health screening via Personal Health Questionnaire Depression Scale (PHQ-8)
timeFrame: Baseline and up to 90 Days
measure: Change in Mental health screening via General Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline and up to 90 Days
measure: Change in COVID Symptom Checklist
timeFrame: Baseline and up to 90 Days
measure: AffloVest Usage
timeFrame: 90 Days
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Patricia Walker, MD
role: PRINCIPAL_INVESTIGATOR
References: