The Use of Airway Clearance Devices in ALS

NCT02682030 | Completed Results FDA Device

• 1 other identifier: Pro00039699
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Airway Clearance Devices; High Frequency Chest Compression Devices; Cough Assist

Outcome Measures

Primary Outcomes (6)

• Number of Subjects With Improved Respiratory Symptoms as Shown by Chest X-Ray Between Baseline and End of Study

  A projection radiograph of the chest used to diagnose conditions affecting the chest. Chest X-Ray performed at each study visit. Investigator looked at clinical impression of Chest X-ray to be normal versus abnormal. If there was presence of atelectasis, this indicated a worsening of subject's respiratory symptoms. If subject's Chest X-Ray impression remained the same and continually normal, this indicated no change in respiratory symptoms.

  1 time at screening/baseline and then at the month 1, month 3, and month 6 study visit for a total of 4 X-rays over 6 months.

• Number of Subjects With Improved Respiratory Symptoms As Shown By Lung Ventilation Scan Between Baseline and End of Study

  A nuclear scanning test commonly used to detect abnormalities in air flow. A radioactive tracer gas or mist is inhaled into the lungs. Pictures from the scan indicate areas of the lungs that are not receiving enough air or that retain too much air. Areas of the lung that retain too much air are brighter spots on the film and areas not receiving enough air are dark. Lung scan performed at each study visit. Investigator looked at clinical impression of lung scan to be normal versus abnormal. If there was indication of decreased ventilation, this indicated a worsening of subject's respiratory symptoms. If subject's lung scan impression remained the same and continually normal, this indicated no change in respiratory symptoms.

  1 time at screening/baseline and then at the month 1, month 3, and month 6 study visit for a total of 4 lung ventilation scans over 6 months.

• Number of Participants With Increased McGill Single Item Quality of Life Scale Question Between Baseline and End of Study

  Assess the improvement of/ rate of deterioration of the subject's quality of life from baseline to end of study on a rated scale of 1 to 10.

  1 time at screening/baseline and then at the month 1, month 3, and month 6 study visit for a total of 4 questionnaires over 6 months.

• Number of Participants With Improved Forced Vital Capacity (FVC) Between Baseline and End of Study

  Spirometry will be used to measure FVC. It is the most common of the pulmonary function tests and measures lung function, specifically the measurement of the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled.

  1 time at screening/baseline and then at the month 1, month 3, and month 6 study visit for a total of 4 testing sessions over 6 months.

• Number of Participants With Improved Maximal Inspiratory Pressure (MIP) Between Baseline and End of Study

  Spirometry will be used to measure MIP. It is the most common of the pulmonary function tests and measures lung function, specifically the measurement of the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled.

  1 time at screening/baseline and then at the month 1, month 3, and month 6 study visit for a total of 4 testing sessions over 6 months.

• Number of Participants With Improved Diffusion Capacity Between Baseline and End of Study

  Spirometry will be used to measure Diffusion Capacity. It is the most common of the pulmonary function tests and measures lung function, specifically the measurement of the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled.

  1 time at screening/baseline and then at the month 1, month 3, and month 6 study visit for a total of 4 testing sessions over 6 months.

Study Arms (2)

Treatment group A

ACTIVE COMPARATOR

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.

Device: High Frequency Chest Compression Device (HFCC)

Treatment group B- HFCC and Cough Assist

ACTIVE COMPARATOR

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.

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

Interventions

High Frequency Chest Compression Device (HFCC) DEVICE

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

Treatment group A; Treatment group B- HFCC and Cough Assist

Cough Assist DEVICE

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

Treatment group B- HFCC and Cough Assist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any contraindication for pulmonary ventilation scan including allergy to radioisotopes
• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

Data too limited to address the aims and perform statistical analyses between the groups. 5 subjects were enrolled, only two completed the study, and the one that was randomized for HFCC only did not have any follow up visit.

Results Point of Contact

• Title: Dr. Ashraf Elsayegh
• Organization: Cedars Sinai Medical Center - 8700

ashraf.elsayegh@cshs.org

3105560335

Study Officials

• Ashraf Elsayegh, MD, FCCP

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor, UCLA School of Medicine

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 15, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 25, 2020
• Results First Posted: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)