The Use of Airway Clearance Devices in ALS

Cedars-Sinai Medical Center

Status: Completed

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Device: Cough Assist; Device: High Frequency Chest Compression Device (HFCC)

Study type: Interventional

Funder types: Other

Identifiers

NCT02682030

Pro00039699

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Suspected, possible, probable, Probable (Lab-Supported), or Definite ALS according to El Escorial Criteria
2. Males and females age 18 and above
3. Novel to airway clearance device use
4. Forced vital capacity ≤ 75% of predicted

Exclusion criteria

1. Any contraindication for pulmonary ventilation scan including allergy to radioisotopes

2. Any contraindication for use of a pulmonary clearance device

   • Susceptibility to pneumothorax
   • Recent (within 30 days) barotrauma
   • Unstable head or neck injury
   • Active hemorrhage with hemodynamic instability

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Treatment group A

Active Comparator group

Description:

Subjects randomized to group A will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device for home use. Subjects will be instructed to use the HFCC device 2-3 times per day for 15-30 minutes each. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.

Treatment:

Device: High Frequency Chest Compression Device (HFCC)

Treatment group B- HFCC and Cough Assist

Active Comparator group

Description:

Subjects randomized to group B will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device and will also be issued a cough assist device. Subjects will be instructed in the use of both devices. The HFCC device should be utilized 2-3 times per day for 15-30 minutes each followed by a session with the cough assist. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.

Treatment:

Device: High Frequency Chest Compression Device (HFCC)

Device: Cough Assist