Hill-Rom - Clinical Trial of The Vest

Name of Clinical Trial/Study:

Multicenter study using High-frequency Chest Wall Oscillation (HFCWO) to reduce the incidence and duration of pulmonary complications in patients with ALS

This study has concluded.  To view results, please click here.

Click here for more information on The Vest^TM.

Updated 08/2009

Purpose and Rationale:

The manufacturer reports that experience with HFCWO via The Vest^TM in other diagnoses has shown reduced hospitalizations, decreased need for antibiotics, improved quality of life and improved pulmonary function scores. This study will assess pulmonary function with and without HFCWO and measure pulmonary complications in patients with ALS. 

Study Details:

This is a randomized, parallel study design with two arms: Vest treatment and non-vest treatment. It will be conducted at six sites nationwide. Participants completed baseline surveys, underwent pulmonary function testing and CO₂ and oxygen saturation measurements. These measurements and surveys were taken during clinic visits at 4 and 12 weeks. Also, participants were required to take a daily Peak Expiratory Flow (PEF) measurement (a pulmonary function test), and completed a daily log recording PEF scores and tracking use of HFCWO therapy (for the treatment arm). At the end of three months, participants in both the treatment and non-vest treatment arms had the option to use HFCWO for the next 6 months, submitting additional survey and pulmonary function measurements at 24 and 36 weeks.

Advanced Respiratory, Inc, is the study sponsor with Dr. Hiroshi Mitsumoto serving as the medical advisor for the trial.

Eligibility Requirements:

Inclusion criteria:

1. Meet El Escorial Criteria for probable or definite ALS
2. Have evidence of respiratory involvement as evidenced by the ALS Functional Rating-Respiratory subscale (ALS FRS R) of < 11
3. Have no previous experience with use of HFCWO

Exclusion criteria:

1. Patient cannot tolerate prescribed therapy
2. Vest use is contraindicated
3. Anticipated mortality during period of study
4. FVC < 40%
5. ALS FRS R-Respiratory subscale score < 5
6. Tracheostomy
7. Current use of cough assist device (In/exsufflator)
8. Clinical signs of congestive heart failure
9. Current participation in other therapeutic trials for treatment of ALS