NCT03628456

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 13, 2018

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2019

Completed
4 months until next milestone

Results Posted

Study results publicly available

November 13, 2019

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

8 days

First QC Date

August 9, 2018

Results QC Date

October 24, 2019

Last Update Submit

November 13, 2019

Conditions

Cystic FibrosisBronchiectasis

Outcome Measures

Primary Outcomes (5)

  • 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

    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

    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

    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

    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

    30 minutes

Study Arms (1)

AffloVest Monarch Arm

EXPERIMENTAL

Devices placed on highest intensity / highest frequency

Device: International Biophysics AffloVestDevice: Hill-Rom Monarch

Interventions

International Biophysics AffloVestDEVICE

High-frequency chest wall oscillation vest

AffloVest Monarch Arm
Hill-Rom MonarchDEVICE

High-frequency chest wall oscillation vest

AffloVest Monarch Arm

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Healthy subject, ages 18 - 50

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PDS Research

Kissimmee, Florida, 34741, United States

Location

MeSH Terms

Conditions

Cystic FibrosisBronchiectasis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesBronchial Diseases

Results Point of Contact

Title
VP of Engineering and Quality
Organization
International Biophysics Corporation
quality@biophysicscorp.com
512-804-0046

Study Officials

  • Thomas W O'Brien, MD

    PDS Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2018

First Posted

August 14, 2018

Study Start

September 13, 2018

Primary Completion

September 21, 2018

Study Completion

July 2, 2019

Last Updated

November 22, 2019

Results First Posted

November 13, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)