TerminatedNot Applicable

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

Stopped: only one participant enrolled, results will not be provided due to risk of breach of confidentiality

United States1 participantsStarted 2021-07-20

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in forced expiratory volume in one second (FEV1)

Timeframe: Baseline and up to 90 Days

Change in Oxygen Saturation level

Timeframe: Baseline and up to 90 Days

Change in Presence of Fever

Timeframe: Baseline and up to 90 Days

Trial details

NCT IDNCT04654481

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-19

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.