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Electro Flo 5000 and Vest Therapy (EF/Vest)

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ClinicalTrials.gov Identifier: NCT02277626
Recruitment Status : Completed
First Posted : October 29, 2014
Results First Posted : January 12, 2016
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Carlos Milla, Stanford University

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Device: Electro Flo 5000 Device: Incourage Vest System Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and Vest Therapy in
Study Start Date : April 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Randomized Crossover to ElectroFlo
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.
Device: Electro Flo 5000
Airway clearance device

Experimental: Randomized Crossover to Vest
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.
Device: Incourage Vest System
Airway Clearance Device




Primary Outcome Measures :
  1. Wet Sputum Weight [ Time Frame: End of study visit per intervention ]
    Sputum was collected in pre-measured cups in a blinded fashion

  2. Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST. [ Time Frame: End of study visit per intervention ]
    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.

  3. Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest. [ Time Frame: End of study visit per intervention ]
    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.

  4. Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest [ Time Frame: End of study visit per intervention ]
    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 :
  1. Dry Sputum Weight [ Time Frame: End of study visit per intervention ]
    Sputum was collected in pre-measured cups in a blinded fashion, dessicated and measured dry



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. -
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Responsible Party: Carlos Milla, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02277626    
Other Study ID Numbers: 24248
First Posted: October 29, 2014    Key Record Dates
Results First Posted: January 12, 2016
Last Update Posted: January 12, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases