Bronchiectasis, Cystic Fibrosis
Conditions
Brief 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.
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.
Interventions
High-frequency chest wall oscillation vest
DEVICEHill-Rom The Vest
High-frequency chest wall oscillation vest
DEVICERespirtech inCourage
High-frequency chest wall oscillation vest
DEVICEElectromed SmartVest
High-frequency chest wall oscillation vest
Sponsors
International Biophysics Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subject, ages 18 - 50
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TV | 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 | 30 minutes | Peak Expiratory Flow, a person's maximum speed of expiration |
| FVC | 30 minutes | Forced Vital Capacity, the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible |
| FEV1 | 30 minutes | Forced Expiratory Volume, the volume of air that can be forced out in one second after taking a deep breath |
| FEF25-75% | 30 minutes | Forced Expiratory Flow (25-75%), the peak expiratory flow at 25 - 75% FVC |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AffloVest The Vest Arm Devices placed on highest intensity / highest frequency
International Biophysics AffloVest: High-frequency chest wall oscillation vest
Hill-Rom The Vest: High-frequency chest wall oscillation vest | 10 |
| AffloVest inCourage Arm Devices placed on highest intensity / highest frequency
International Biophysics AffloVest: High-frequency chest wall oscillation vest
Respirtech inCourage: High-frequency chest wall oscillation vest | 10 |
| AffloVest SmartVest Arm Devices placed on highest intensity / highest frequency
International Biophysics AffloVest: High-frequency chest wall oscillation vest
Electromed SmartVest: High-frequency chest wall oscillation vest | 12 |
| Total | 32 |
Baseline characteristics
| Characteristic | AffloVest inCourage Arm | AffloVest SmartVest Arm | AffloVest The Vest Arm | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 12 Participants | 10 Participants | 32 Participants |
| Age, Continuous | 30.6 years STANDARD_DEVIATION 13.3 | 34.7 years STANDARD_DEVIATION 10.2 | 28.4 years STANDARD_DEVIATION 11.9 | 31.7 years STANDARD_DEVIATION 11.7 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 10 participants | 12 participants | 10 participants | 32 participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 2 Participants | 13 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 8 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 12 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 12 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 12 |
Outcome results
Primary
FEF25-75%
Forced Expiratory Flow (25-75%), the peak expiratory flow at 25 - 75% FVC
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Baseline | FEF25-75% | 3.71 L/s |
| AffloVest Arm | FEF25-75% | 3.54 L/s |
| Compressor Arm | FEF25-75% | 3.19 L/s |
Primary
FEV1
Forced Expiratory Volume, the volume of air that can be forced out in one second after taking a deep breath
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Baseline | FEV1 | 3.51 L |
| AffloVest Arm | FEV1 | 3.46 L |
| Compressor Arm | FEV1 | 3.30 L |
Primary
FVC
Forced Vital Capacity, the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Baseline | FVC | 4.29 L |
| AffloVest Arm | FVC | 4.25 L |
| Compressor Arm | FVC | 4.12 L |
Primary
PEF
Peak Expiratory Flow, a person's maximum speed of expiration
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Baseline | PEF | 8.19 L/s |
| AffloVest Arm | PEF | 8.28 L/s |
| Compressor Arm | PEF | 8.13 L/s |
Primary
TV
Tidal Volume, the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Baseline | TV | 0.93 L |
| AffloVest Arm | TV | 1.00 L |
| Compressor Arm | TV | 1.07 L |