N/A
N=32
Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements
Cystic Fibrosis · Bronchiectasis
Bottom Line
View on ClinicalTrials.gov: NCT03534986 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: TV — 0.93; 1.00; 1.07 L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- International Biophysics AffloVest (Device); Hill-Rom The Vest (Device); Respirtech inCourage (Device); Electromed SmartVest (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- International Biophysics Corporation
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY TV |
0.93; 1.00; 1.07 | — |
| PRIMARY PEF |
8.19; 8.28; 8.13 | — |
| PRIMARY FVC |
4.29; 4.25; 4.12 | — |
| PRIMARY FEV1 |
3.51; 3.46; 3.30 | — |
| PRIMARY FEF25-75% |
3.71; 3.54; 3.19 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03534986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.