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The Use of Airway Clearance Devices in ALS

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ClinicalTrials.gov Identifier: NCT02682030
Recruitment Status : Completed
First Posted : February 15, 2016
Results First Posted : August 25, 2020
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Ashraf Elsayegh, Cedars-Sinai Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Device: High Frequency Chest Compression Device (HFCC) Device: Cough Assist Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Utilization of Pulmonary Clearance Devices in Amyotrophic Lateral Sclerosis
Study Start Date : March 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 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.
Active Comparator: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With Improved Respiratory Symptoms as Shown by Chest X-Ray Between Baseline and End of Study [ Time Frame: 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. ]
    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.

  2. Number of Subjects With Improved Respiratory Symptoms As Shown By Lung Ventilation Scan Between Baseline and End of Study [ Time Frame: 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. ]
    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.

  3. Number of Participants With Increased McGill Single Item Quality of Life Scale Question Between Baseline and End of Study [ Time Frame: 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. ]
    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.

  4. Number of Participants With Improved Forced Vital Capacity (FVC) Between Baseline and End of Study [ Time Frame: 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. ]
    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.

  5. Number of Participants With Improved Maximal Inspiratory Pressure (MIP) Between Baseline and End of Study [ Time Frame: 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. ]
    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.

  6. Number of Participants With Improved Diffusion Capacity Between Baseline and End of Study [ Time Frame: 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. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682030


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Ashraf Elsayegh, MD, FCCP Cedars-Sinai Medical Center
  Study Documents (Full-Text)

Documents provided by Ashraf Elsayegh, Cedars-Sinai Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] April 18, 2016

More Information
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Responsible Party: Ashraf Elsayegh, Assistant Clinical Professor, UCLA School of Medicine, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02682030    
Other Study ID Numbers: Pro00039699
First Posted: February 15, 2016    Key Record Dates
Results First Posted: August 25, 2020
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Ashraf Elsayegh, Cedars-Sinai Medical Center:
Airway Clearance Devices
High Frequency Chest Compression Devices
Cough Assist
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases