Electro Flo 5000 and Vest Therapy (EF/Vest)

Stanford University

Status and phase: Completed; Phase 4

Conditions: Cystic Fibrosis

Treatments: Device: Electro Flo 5000; Device: Incourage Vest System

Study type: Interventional

Funder types: Other

Identifiers

NCT02277626

24248

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 12+ years old

Volunteers: No 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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Randomized Crossover to ElectroFlo

Experimental group

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.

Treatment:

Device: Electro Flo 5000

Randomized Crossover to Vest

Experimental group

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.

Treatment:

Device: Incourage Vest System