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

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ClinicalTrials.gov Identifier: NCT04654481
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : December 4, 2020
Sponsor:
Collaborators:
International Biophysics Corporation
SPARK Healthcare
Information provided by (Responsible Party):
Patricia Walker, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Chronic Cough Covid19 Device: HCFWO Other: Standard Care Plus Monitoring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Statistician and data analysts will be blinded to treatment cohort.
Primary Purpose: Supportive Care
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
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : November 2021

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.
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

Other: Standard Care Plus Monitoring
Monitoring via home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments.




Primary Outcome Measures :
  1. Change in forced expiratory volume in one second (FEV1) [ Time Frame: Baseline and up to 90 Days ]
    Change in forced expiratory volume in one second (FEV1) as compared to baseline, measured by home spirometer.

  2. Change in Oxygen Saturation level [ Time Frame: 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.

  3. Change in Presence of Fever [ Time Frame: 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 Outcome Measures :
  1. Change in Presence of pneumonia symptoms via Community Acquired Pneumonia (CAP) Symptom Questionnaire [ Time Frame: 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.

  2. Change in Quality of life via Quality of Life Questionnaire-Respiratory (QOL-B) [ Time Frame: 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.

  3. Change in Mental health screening via Personal Health Questionnaire Depression Scale (PHQ-8) [ Time Frame: 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.

  4. Change in Mental health screening via General Anxiety Disorder-7 (GAD-7) [ Time Frame: 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.

  5. Change in COVID Symptom Checklist [ Time Frame: 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.

  6. AffloVest Usage [ Time Frame: 90 Days ]
    Amount of time used per week in minutes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04654481


Contacts
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Contact: Elinor L Schwind, MS (212) 420-4100 Elinor.Schwind@mountsinai.org
Contact: Teresa Demarco, PTA 212-420-4100 teresa.demarco@mountsinai.org

Locations
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United States, New York
Mount Sinai Beth Israel Recruiting
New York, New York, United States, 10003
Contact: Elinor L Schwind, MS    212-420-4100    Elinor.Schwind@mountsinai.org   
Principal Investigator: Patricia Walker, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
International Biophysics Corporation
SPARK Healthcare
Investigators
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Principal Investigator: Patricia Walker, MD Icahn School of Medicine at Mount Sinai
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Responsible Party: Patricia Walker, Co-Director, The Cystic Fibrosis Center, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04654481    
Other Study ID Numbers: GCO 20-2667
ISMMS-AFF-20 ( Other Identifier: International Biophysics, Inc. )
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Patricia Walker, Icahn School of Medicine at Mount Sinai:
Pulmonary Disease
Airway Clearance Therapy
High Frequency Chest Wall Oscillation
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases