Chronic Obstructive Pulmonary DiseaseNCT04654481
Study of AffloVest in At-Risk Respiratory Patients During COVID-19 Pandemic
A study testing HCFWO in people with Chronic Obstructive Pulmonary Disease and Chronic Cough, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Chronic Cough, Covid19
- What is being tested?
- HCFWO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2021to 19 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- HCFWO, Standard Care Plus Monitoring
- Keywords
- Pulmonary Disease, Airway Clearance Therapy, High Frequency Chest Wall Oscillation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Chronic Cough, COVID-19, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCFWODevice
Also called 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 MonitoringOther
Monitoring via home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Plus Monitoring | Active comparator | All subjects will be monitored via home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments. Receives: Other: Standard Care Plus Monitoring |
| Standard Care Plus Monitoring and HCFWO | Experimental | 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. Receives: Device: HCFWO; Other: Standard Care Plus Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and up to 90 Days
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and up to 90 Days
AffloVest Usage
Amount of time used per week in minutes
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start20 Jul 2021
- Primary completion19 Oct 2021
- Study completion19 Oct 2021
Why it stopped: only one participant enrolled, results will not be provided due to risk of breach of confidentiality
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- International Biophysics Corporation, SPARK Healthcare
- Responsible party
- Principal investigator, Patricia Walker, Icahn School of Medicine at Mount Sinai
- Investigators
- Patricia Walker, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654481
- Sponsor's protocol ID
- GCO 20-2667
- Other IDs
- ISMMS-AFF-20
- Status last verified
- Apr 2022
- First submitted
- 3 Dec 2020
- Last updated
- 5 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04654481
- Acronym / sponsor ID
- GCO 20-2667
- Keywords
- Pulmonary Disease, Airway Clearance Therapy, High Frequency Chest Wall Oscillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: only one participant enrolled, results will not be provided due to risk of breach of confidentiality
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- International Biophysics Corporation, SPARK Healthcare
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Plus Monitoring | Active comparator | Other: Standard Care Plus MonitoringAll subjects will be monitored via home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments. |
| Standard Care Plus Monitoring and HCFWO | Experimental | Device: HCFWO, Other: Standard Care Plus MonitoringIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- Presenting with hypoxia (02 sat <90%)
- Acute COVID-19 infection
- Home oxygen dependent
- Established diagnosis of cystic fibrosis
- History of osteoporosis or rib fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCFWOAlso: High Frequency Chest Wall Oscillation, AfflovestThe 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. | Device | Standard Care Plus Monitoring and HCFWO |
| Standard Care Plus MonitoringMonitoring via home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments. | Other | Standard Care Plus Monitoring, Standard Care Plus Monitoring and HCFWO |
Primary outcome
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.
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.
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.
6 secondary outcomes
Change in Presence of pneumonia symptoms via Community Acquired Pneumonia (CAP) Symptom Questionnaire
Time frame: Baseline and up to 90 Days
Change in Quality of life via Quality of Life Questionnaire-Respiratory (QOL-B)
Time frame: Baseline and up to 90 Days
Change in Mental health screening via Personal Health Questionnaire Depression Scale (PHQ-8)
Time frame: Baseline and up to 90 Days
Change in Mental health screening via General Anxiety Disorder-7 (GAD-7)
Time frame: Baseline and up to 90 Days
Change in COVID Symptom Checklist
Time frame: Baseline and up to 90 Days
AffloVest Usage
Time frame: 90 Days
Results and safety
The study was stopped early (reason given: only one participant enrolled, results will not be provided due to risk of breach of confidentiality). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Walker, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCFWO in people with Chronic Obstructive Pulmonary Disease and Chronic Cough, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: only one participant enrolled, results will not be provided due to risk of breach of confidentiality). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in forced expiratory volume in one second (FEV1) (time frame: Baseline and up to 90 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.