Electro Flo 5000 and Vest Therapy

Phase 4

Completed

• Conditions: Cystic Fibrosis
• Interventions: Device: Electro Flo 5000; Device: Incourage Vest System

• Registration Number: NCT02277626
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-29
• Results First Submitted: 2015-08-13
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-07
• Last Update Submitted: 2015-12-07
• Results First Posted: 2016-01-12
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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).

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Randomized Crossover to ElectroFlo	Electro Flo 5000	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.
Randomized Crossover to Vest	Incourage 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.

Primary Outcome Measures

Name	Time	Method
Wet Sputum Weight	End of study visit per intervention	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.	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.
Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest.	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.
Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest	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

Name	Time	Method
Dry Sputum Weight	End of study visit per intervention	Sputum was collected in pre-measured cups in a blinded fashion, dessicated and measured dry