The Use of Airway Clearance Devices in ALS

NCT ID: NCT02682030

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group A

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.

Group Type: ACTIVE_COMPARATOR

High Frequency Chest Compression Device (HFCC)

Intervention Type: DEVICE

A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.

Treatment group B- HFCC and Cough Assist

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.

Group Type: ACTIVE_COMPARATOR

High Frequency Chest Compression Device (HFCC)

Intervention Type: DEVICE

A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.

Cough Assist

Intervention Type: DEVICE

A device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing.

Interventions

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.

Intervention Type: DEVICE

Cough Assist

A device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ashraf Elsayegh

Assistant Clinical Professor, UCLA School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashraf Elsayegh, MD, FCCP

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00039699

Identifier Type: -

Identifier Source: org_study_id