Cystic FibrosisNCT03534986
Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements
A study testing International Biophysics AffloVest, Hill-Rom The Vest and Respirtech inCourage 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, Hill-Rom The Vest and Respirtech inCourage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2018to 16 Mar 2018
- 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
Trial locations and contacts
1 site in 1 country.
About this 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 three (3) arms:
- AffloVest® \& The Vest®
- AffloVest® \& inCourage®
- AffloVest® \& SmartVest® Subjects will be randomly assigned to an arm. Within each arm, the order of products will be also 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 Compressor-based vest) 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 The Vest, Respirtech inCourage, Electromed SmartVest
- 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 The VestDevice
High-frequency chest wall oscillation vest
Respirtech inCourageDevice
High-frequency chest wall oscillation vest
Electromed SmartVestDevice
High-frequency chest wall oscillation vest
| Study group | Role | What they receive |
|---|---|---|
| AffloVest The Vest Arm | Experimental | Devices placed on highest intensity / highest frequency Receives: Device: International Biophysics AffloVest; Device: Hill-Rom The Vest |
| AffloVest inCourage Arm | Experimental | Devices placed on highest intensity / highest frequency Receives: Device: International Biophysics AffloVest; Device: Respirtech inCourage |
| AffloVest SmartVest Arm | Experimental | Devices placed on highest intensity / highest frequency Receives: Device: International Biophysics AffloVest; Device: Electromed SmartVest |
What is being measured
The primary outcome is the main question the study is designed to answer.
TV
Tidal Volume, the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied
Measured: 30 minutes
PEF
Peak Expiratory Flow, a person's maximum speed of expiration
Measured: 30 minutes
FVC
Forced Vital Capacity, the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible
Measured: 30 minutes
FEV1
Forced Expiratory Volume, the volume of air that can be forced out in one second after taking a deep breath
Measured: 30 minutes
FEF25-75%
Forced Expiratory Flow (25-75%), the peak expiratory flow at 25 - 75% FVC
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 posted23 May 2018
- Study start20 Feb 2018
- Primary completion16 Mar 2018
- Study completion16 Mar 2018
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT03534986
- Sponsor's protocol ID
- 2017-02
- Status last verified
- Sep 2018
- First submitted
- 14 May 2018
- Last updated
- 3 Oct 2018
- 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 3 Oct 2018. 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
- ClinicalTrials.gov ID
- NCT03534986
- Acronym / sponsor ID
- 2017-02
- Conditions
- Cystic Fibrosis, Bronchiectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- International Biophysics CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 16 Mar 2018 (actual)
- Study completion
- 16 Mar 2018 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Posted 6 Sep 2018
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 three (3) arms:
- AffloVest® \& The Vest®
- AffloVest® \& inCourage®
- AffloVest® \& SmartVest® Subjects will be randomly assigned to an arm. Within each arm, the order of products will be also 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 Compressor-based vest) 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AffloVest The Vest Arm | Experimental | Device: International Biophysics AffloVest, Device: Hill-Rom The VestDevices placed on highest intensity / highest frequency |
| AffloVest inCourage Arm | Experimental | Device: International Biophysics AffloVest, Device: Respirtech inCourageDevices placed on highest intensity / highest frequency |
| AffloVest SmartVest Arm | Experimental | Device: International Biophysics AffloVest, Device: Electromed SmartVestDevices 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 (1 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, non-English speaking
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 SmartVest Arm, AffloVest The Vest Arm, AffloVest inCourage Arm |
| Hill-Rom The VestHigh-frequency chest wall oscillation vest | Device | AffloVest The Vest Arm |
| Respirtech inCourageHigh-frequency chest wall oscillation vest | Device | AffloVest inCourage Arm |
| Electromed SmartVestHigh-frequency chest wall oscillation vest | Device | AffloVest SmartVest Arm |
Primary outcome
TV
Time frame: 30 minutes
Tidal Volume, the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied
PEF
Time frame: 30 minutes
Peak Expiratory Flow, a person's maximum speed of expiration
FVC
Time frame: 30 minutes
Forced Vital Capacity, the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible
FEV1
Time frame: 30 minutes
Forced Expiratory Volume, the volume of air that can be forced out in one second after taking a deep breath
FEF25-75%
Time frame: 30 minutes
Forced Expiratory Flow (25-75%), the peak expiratory flow at 25 - 75% FVC
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- 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, Hill-Rom The Vest and Respirtech inCourage 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 1 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 3 Oct 2018. 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 6 Sep 2018). 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?
TV (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 3 Oct 2018.