Electro Flo 5000 and Vest Therapy

Stanford University15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cystic Fibrosis

Interventions

Electro Flo 5000DEVICE

Airway clearance device

Incourage Vest SystemDEVICE

Airway Clearance Device

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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. -