Clinical trial NCT02682030: The Use of Airway Clearance Devices in ALS
Official title: Utilization of Pulmonary Clearance Devices in Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Airway Clearance Devices
High Frequency Chest Compression Devices
Cough Assist
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Subjects With Improved Respiratory Symptoms as Shown by Chest X-Ray Between Baseline and End of Study
timeFrame: 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.
measure: Number of Subjects With Improved Respiratory Symptoms As Shown By Lung Ventilation Scan Between Baseline and End of Study
timeFrame: 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.
measure: Number of Participants With Increased McGill Single Item Quality of Life Scale Question Between Baseline and End of Study
timeFrame: 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.
measure: Number of Participants With Improved Forced Vital Capacity (FVC) Between Baseline and End of Study
timeFrame: 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.
measure: Number of Participants With Improved Maximal Inspiratory Pressure (MIP) Between Baseline and End of Study
timeFrame: 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.
measure: Number of Participants With Improved Diffusion Capacity Between Baseline and End of Study
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Ashraf Elsayegh, MD, FCCP
role: PRINCIPAL_INVESTIGATOR
References: