Utilization of Pulmonary Clearance Devices in Amyotrophic Lateral Sclerosis

Study Purpose:

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).

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Device

Study Status:

Active, not yet recruiting

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Ashraf Elsayegh, MD, FCCP, Cedars-Sinai Medical Center

Clinicaltrials.gov ID (11 digit #):

NCT02682030

Neals Affiliated?

No

Coordinating Center Contact Information

Cedars-Sinai Medical Center
K. Ashley Fetterman / .(JavaScript must be enabled to view this email address) / 310-423-1791
.(JavaScript must be enabled to view this email address) Los Angeles, California 90048 United States

Full Study 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.

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 Sponsor:

Cedars-Sinai Medical Center

Participant Duration:

Estimated Enrollment:

20

Estimated Study Start Date:

02/29/2016

Estimated Study Completion Date:

02/28/2018

Posting Last Modified Date:

02/29/2016

Date Study Added to alsconsortium.org:

03/01/2016
  • More Information
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?


    Inclusion Criteria:
    -Suspected, possible, probable, Probable (Lab-Supported), or Definite ALS according to El Escorial Criteria
    -Novel to airway clearance device use
    -Forced vital capacity ≤ 75% of predicted

    Exclusion Criteria:
    -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

  • Site Contact Information

    Cedars-Sinai Medical Center
    K. Ashley Fetterman / 310-423-1791
    Los Angeles, California 90048
    United States