Cystic FibrosisNCT03628456
Effect of HFCWO Vests on Spirometry Measurements
A study testing International Biophysics AffloVest and Hill-Rom Monarch in people with Cystic Fibrosis and Bronchiectasis, run by International Biophysics Corporation at 1 site in United States.
Trial summary
The impact of high-frequency chest wall oscillation therapy on spirometry values (Forced Expiratory Volume, Forced Vital Capacity, Peak Expiratory Flow, Forced Expiratory Flow and Tidal Volume is investigated during use of several products and comparing to baseline values Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Bronchiectasis
- What is being tested?
- International Biophysics AffloVest and Hill-Rom Monarch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2018to 2 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subject, ages 18 - 50
Who cannot join
- Non-ambulatory
- diagnosed neuromuscular disorder
- currently using any type of oscillation vest therapy
- diagnosed co-morbid condition (i.e. lung cancer, other lung disorder or disease)
- currently enrolled in a medical research study
- non-English speaking
Show all 9Show fewer
- presence of the following active implantable devices: pacemakers, neurostimulators, infusion pumps, circulatory support devices, implantable cardioverter defibrillators (ICD's), cochlear implants
- presence of head and/or neck injury that has not yet been stabilized
- presence of active hemorrhage with hemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements, Comparative Study
The impact of high-frequency chest wall oscillation therapy on spirometry values (Forced Expiratory Volume, Forced Vital Capacity, Peak Expiratory Flow, Forced Expiratory Flow and Tidal Volume is investigated during use of several products and comparing to baseline values
Read the detailed description
The study will be broken into one (1) arm:
- AffloVest® \& Monarch™
Within the arm, the order of products will be randomized.
Baseline spirometry (Forced Expiratory Volume (FEV1), Forced Vital Capacity (FVC), Peak Expiratory Flow (PEF), Forced Expiratory Flow (FEF25-75%) and Tidal Volume (TV)) will be taken at the beginning, middle and end of each series of measurements with each subject, without any device on the subject. A product (AffloVest or Monarch) will be placed onto subject and turned ON to the highest frequency and intensity settings. Then the subject will be given a certain period of time to adjust and spirometry measurements will then be repeated, then the product will be removed and the subject will be allowed a recovery period, then the other product will be placed on the subject, turned ON and spirometry measurements will repeated.
- Conditions
- Cystic Fibrosis, Bronchiectasis
- Being tested
- International Biophysics AffloVest, Hill-Rom Monarch
- Medical subject headings
- Cystic Fibrosis, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
International Biophysics AffloVestDevice
High-frequency chest wall oscillation vest
Hill-Rom MonarchDevice
High-frequency chest wall oscillation vest
| Study group | Role | What they receive |
|---|---|---|
| AffloVest Monarch Arm | Experimental | Devices placed on highest intensity / highest frequency Receives: Device: International Biophysics AffloVest; Device: Hill-Rom Monarch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices
Tidal Volume is the normal volume of air displaced between normal inhalation and exhalation, measured using standard sprirometry techniques
Measured: 30 minutes
Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices
Peak Expiratory Flow (PEF) measures the peak flow during a forced exhalation, measured using standard spirometry techniques
Measured: 30 minutes
Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices
Forced Vital Capacity (FVC) is the total amount of air exhaled during the FEV test, measured using standard spirometry techniques
Measured: 30 minutes
Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices
Forced Expiratory Volume in 1 second (FEV1) measures how much air a person can exhale during a forced breath during the first one (1) second, measured using standard spirometry techniques
Measured: 30 minutes
Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices
Forced Expiratory Flow (25-75%) is the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled, measured using standard spirometry techniques
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start13 Sep 2018
- Primary completion21 Sep 2018
- Study completion2 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Biophysics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas W O'Brien, MD, Principal investigator, PDS Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628456
- Sponsor's protocol ID
- 2018-01
- Status last verified
- Nov 2019
- First submitted
- 9 Aug 2018
- Last updated
- 22 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements, Comparative Study
- ClinicalTrials.gov ID
- NCT03628456
- Acronym / sponsor ID
- 2018-01
- Conditions
- Cystic Fibrosis, Bronchiectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- International Biophysics CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 21 Sep 2018 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Posted 13 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The impact of high-frequency chest wall oscillation therapy on spirometry values (Forced Expiratory Volume, Forced Vital Capacity, Peak Expiratory Flow, Forced Expiratory Flow and Tidal Volume is investigated during use of several products and comparing to baseline values
Detailed description
The study will be broken into one (1) arm:
- AffloVest® \& Monarch™
Within the arm, the order of products will be randomized.
Baseline spirometry (Forced Expiratory Volume (FEV1), Forced Vital Capacity (FVC), Peak Expiratory Flow (PEF), Forced Expiratory Flow (FEF25-75%) and Tidal Volume (TV)) will be taken at the beginning, middle and end of each series of measurements with each subject, without any device on the subject. A product (AffloVest or Monarch) will be placed onto subject and turned ON to the highest frequency and intensity settings. Then the subject will be given a certain period of time to adjust and spirometry measurements will then be repeated, then the product will be removed and the subject will be allowed a recovery period, then the other product will be placed on the subject, turned ON and spirometry measurements will repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AffloVest Monarch Arm | Experimental | Device: International Biophysics AffloVest, Device: Hill-Rom MonarchDevices placed on highest intensity / highest frequency |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subject, ages 18 - 50
Key exclusion criteria (9 listed)
- Non-ambulatory
- diagnosed neuromuscular disorder
- currently using any type of oscillation vest therapy
- diagnosed co-morbid condition (i.e. lung cancer, other lung disorder or disease)
- currently enrolled in a medical research study
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 |
|---|---|---|
| International Biophysics AffloVestHigh-frequency chest wall oscillation vest | Device | AffloVest Monarch Arm |
| Hill-Rom MonarchHigh-frequency chest wall oscillation vest | Device | AffloVest Monarch Arm |
Primary outcome
Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices
Time frame: 30 minutes
Tidal Volume is the normal volume of air displaced between normal inhalation and exhalation, measured using standard sprirometry techniques
Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices
Time frame: 30 minutes
Peak Expiratory Flow (PEF) measures the peak flow during a forced exhalation, measured using standard spirometry techniques
Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices
Time frame: 30 minutes
Forced Vital Capacity (FVC) is the total amount of air exhaled during the FEV test, measured using standard spirometry techniques
Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices
Time frame: 30 minutes
Forced Expiratory Volume in 1 second (FEV1) measures how much air a person can exhale during a forced breath during the first one (1) second, measured using standard spirometry techniques
Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices
Time frame: 30 minutes
Forced Expiratory Flow (25-75%) is the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled, measured using standard spirometry techniques
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Thomas W O'Brien, MD principal investigator
PDS Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing International Biophysics AffloVest and Hill-Rom Monarch in people with Cystic Fibrosis and Bronchiectasis, run by International Biophysics Corporation 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 22 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 13 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices (time frame: 30 minutes). The study lists 5 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 22 Nov 2019.