NCT02682030

The Use of Airway Clearance Devices in ALS

Utilization of Pulmonary Clearance Devices in Amyotrophic Lateral Sclerosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigator is examining the use of one airway clearance medical device compared to the use of two airway clearance medical devices together in patients with amyotrophic lateral sclerosis (ALS). More specifically, the investigator wants to know how effective the use of either a mechanical High Frequency Chest Compression (HFCC) device is on its own or the use of both a mechanical High Frequency Chest Compression (HFCC) device and Cough Assist together to maintain a healthy airway and clear secretions. The first device is a passive form of mechanical High Frequency Chest Compression (HFCC), which was designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area. The second device, called a Cough Assist, aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing. This study will enroll up to 20 people in total at CSMC.

Detailed description

This 180 day (25.7 weeks) pilot study is designed to evaluate the effectiveness of airway clearance devices in adults with ALS. Subjects will be randomized in a 1:1 ratio to one of two treatment groups: treatment with a mechanical HCFF device alone or treatment with both a mechanical HFCC device and a cough assist device. This outpatient study includes a screening/baseline visit followed by a 180 day (25.7 weeks) treatment period with three scheduled clinic visits (day 30, day 90, day 180). Pulmonary assessments and ALS outcome measures will be collected at each visit in addition to quality of life assessments and device usage diaries.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DEVICE	High Frequency Chest Compression Device (HFCC)	A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
DEVICE	Cough Assist	A device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing.

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2016-02-15
• Last updated: 2020-08-25
• Results posted: 2020-08-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study