Clinical trial NCT03628456: Effect of HFCWO Vests on Spirometry Measurements
Official title: Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements, Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Bronchiectasis
Lead sponsor: International Biophysics Corporation
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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
* 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

Primary outcomes:
measure: Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices
timeFrame: 30 minutes
measure: Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices
timeFrame: 30 minutes
measure: Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices
timeFrame: 30 minutes
measure: Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices
timeFrame: 30 minutes
measure: Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kissimmee
country: United States
facility: PDS Research
state: Florida
Study officials:
affiliation: PDS Research
name: Thomas W O'Brien, MD
role: PRINCIPAL_INVESTIGATOR
References: