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Electro Flo 5000 and Vest Therapy (EF/Vest)

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Electro Flo 5000
Incourage Vest System
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of CF established by standard criteria (sweat chloride > 60 mmol/L and/or two alleles affected by gene mutations know to be associated with CF).
  2. Age older than 12 years.
  3. Known to consistently produce sputum.
  4. Currently on a home therapeutic regimen that includes some form of AC performed at least 2 times daily.
  5. FVC and FEV1 > 40%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 3 months).

Exclusion Criteria:

  1. Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.
  2. Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.
  3. Chronic chest pain.
  4. Participation in another interventional clinical trial in the previous 30 days. -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Randomized Crossover to ElectroFlo

    Randomized Crossover to Vest

    Arm Description

    Experimental: ElectroFlo 5000, then VEST Patients are randomized to a sequence of ElectroFlo 5000 on one visit and during the second visit, they cross-over to the Vest system.

    Experimental: VEST, then ElectroFlo 5000 Patients are randomized to a sequence of Vest system on one visit and during the second visit, they cross-over to the ElectroFlo 5000.

    Outcomes

    Primary Outcome Measures

    Wet Sputum Weight
    Sputum was collected in pre-measured cups in a blinded fashion
    Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST.
    Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.
    Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest.
    Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.
    Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest
    Comfort assessed on a scale of 1-10 by patients after therapy after each visit (1 being most comfortable, 10 being most un-comfortable)

    Secondary Outcome Measures

    Dry Sputum Weight
    Sputum was collected in pre-measured cups in a blinded fashion, dessicated and measured dry

    Full Information

    First Posted
    October 27, 2014
    Last Updated
    December 7, 2015
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02277626
    Brief Title
    Electro Flo 5000 and Vest Therapy
    Acronym
    EF/Vest
    Official Title
    Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and Vest Therapy in
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    April 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and VEST therapy) for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health and perform AC at home as part of their routine therapeutic regimen.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cystic Fibrosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Randomized Crossover to ElectroFlo
    Arm Type
    Experimental
    Arm Description
    Experimental: ElectroFlo 5000, then VEST Patients are randomized to a sequence of ElectroFlo 5000 on one visit and during the second visit, they cross-over to the Vest system.
    Arm Title
    Randomized Crossover to Vest
    Arm Type
    Experimental
    Arm Description
    Experimental: VEST, then ElectroFlo 5000 Patients are randomized to a sequence of Vest system on one visit and during the second visit, they cross-over to the ElectroFlo 5000.
    Intervention Type
    Device
    Intervention Name(s)
    Electro Flo 5000
    Intervention Description
    Airway clearance device
    Intervention Type
    Device
    Intervention Name(s)
    Incourage Vest System
    Intervention Description
    Airway Clearance Device
    Primary Outcome Measure Information:
    Title
    Wet Sputum Weight
    Description
    Sputum was collected in pre-measured cups in a blinded fashion
    Time Frame
    End of study visit per intervention
    Title
    Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST.
    Description
    Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.
    Time Frame
    End of study visit per intervention
    Title
    Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest.
    Description
    Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.
    Time Frame
    End of study visit per intervention
    Title
    Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest
    Description
    Comfort assessed on a scale of 1-10 by patients after therapy after each visit (1 being most comfortable, 10 being most un-comfortable)
    Time Frame
    End of study visit per intervention
    Secondary Outcome Measure Information:
    Title
    Dry Sputum Weight
    Description
    Sputum was collected in pre-measured cups in a blinded fashion, dessicated and measured dry
    Time Frame
    End of study visit per intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of CF established by standard criteria (sweat chloride > 60 mmol/L and/or two alleles affected by gene mutations know to be associated with CF). Age older than 12 years. Known to consistently produce sputum. Currently on a home therapeutic regimen that includes some form of AC performed at least 2 times daily. FVC and FEV1 > 40%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 3 months). Exclusion Criteria: Hospitalization for CF pulmonary complications in the 2 months preceding enrollment. Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment. Chronic chest pain. Participation in another interventional clinical trial in the previous 30 days. -

    12. IPD Sharing Statement

    Learn more about this trial

    Electro Flo 5000 and Vest Therapy

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