Amyotrophic Lateral SclerosisNCT02682030

The Use of Airway Clearance Devices in ALS

A study testing High Frequency Chest Compression Device (HFCC) and Cough Assist in people with Amyotrophic Lateral Sclerosis, run by Cedars-Sinai Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Amyotrophic Lateral Sclerosis
What is being tested?: High Frequency Chest Compression Device (HFCC) and Cough Assist
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: Mar 2016to Dec 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Cedars-Sinai Medical Center
Los Angeles, California, 90048

Other trials in United States

About this study

Official title: Utilization of Pulmonary Clearance Devices in Amyotrophic Lateral Sclerosis

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.

Read the 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
Being tested: High Frequency Chest Compression Device (HFCC), Cough Assist
Keywords: Airway Clearance Devices, High Frequency Chest Compression Devices, Cough Assist
Medical subject headings: Amyotrophic Lateral Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02682030
Study group	Role	What they receive
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. Receives: 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. Receives: Device: High Frequency Chest Compression Device (HFCC); Device: Cough Assist

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Dec 2018

First posted15 Feb 2016 (estimated)
Study startMar 2016
Primary completionDec 2018
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02682030
Sponsor's protocol ID: Pro00039699
Status last verified: Aug 2020
First submitted: 4 Feb 2016
Last updated: 25 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Amyotrophic Lateral Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Utilization of Pulmonary Clearance Devices in Amyotrophic Lateral Sclerosis
ClinicalTrials.gov ID: NCT02682030
Acronym / sponsor ID: Pro00039699
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Airway Clearance Devices, High Frequency Chest Compression Devices, Cough Assist
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: Cedars-Sinai Medical CenterUniversity, hospital or other
Study start: Mar 2016
Primary completion: Dec 2018 (actual)
Study completion: Dec 2018 (actual)
First posted: 15 Feb 2016 (estimated)
Results: Posted 25 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment group A	Active comparator	Device: High Frequency Chest Compression Device (HFCC)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.
Treatment group B- HFCC and Cough Assist	Active comparator	Device: High Frequency Chest Compression Device (HFCC), Device: Cough AssistSubjects 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

Any contraindication for pulmonary ventilation scan including allergy to radioisotopes
Any contraindication for use of a pulmonary clearance device

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Treatment group A, Treatment group B- HFCC and Cough Assist
Cough AssistA device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing.	Device	Treatment group B- HFCC and Cough Assist

Primary outcome

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.
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.
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.
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.
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.
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.

Results and safety

Results posted to the registry on 25 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Group A - HFCC Only	1	0
Treatment Group B- HFCC and Cough Assist	4	2

Primary outcome: 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.. Count of participants. Unit: Participants

Measure	Treatment Group A n = 0	Treatment Group B- HFCC and Cough Assist n = 4
Value	0	0

Population analysed: Chest X-ray was not performed for Subject 003 of treatment group A at any visit and therefore was not analyzed. Chest X-ray was performed for Subjects 001, 002, 004, and 005. There was not found to be any improvement of respiratory symptoms across all participants. Not enough data to draw statistical inferences between groups.

Primary outcome: 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.. Count of participants. Unit: Participants

Measure	Treatment Group A - HFCC Only n = 0	Treatment Group B- HFCC and Cough Assist n = 4
Value	0	0

Population analysed: Lung scan was not performed for Subject 003 of treatment group A at any visit and therefore was not analyzed. Lung scan was performed for Subjects 001, 002, 004, and 005. There was not found to be any improvement of respiratory symptoms across all participants. Not enough data to draw statistical inferences between groups.

Primary outcome: 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.. Count of participants. Unit: Participants

Measure	Treatment Group A - HFCC Only n = 0	Treatment Group B- HFCC and Cough Assist n = 2
Value	0	2

Population analysed: Treatment Group A subject 003 did not complete study. Treatment Group B subjects 001 and 005 were only subjects to complete study and reported upward trend of McGill Quality of Life Scale. Not enough data to draw statistical inferences between groups.

Primary outcome: 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.. Count of participants. Unit: Participants

Measure	Treatment Group A - HFCC Only n = 0	Treatment Group B- HFCC and Cough Assist n = 2
Value	0	0

Population analysed: Treatment Group A subject 003 did not complete study. Treatment Group B subjects 001 and 005 were only subjects to complete study and there was a worsening of FVC values for both subjects. Not enough data to draw statistical inferences between groups.

Adverse events

Time frame: 25.7 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Group A - HFCC Only	1 of 1 (100%)	0 of 1 (0%)	1 of 1
Treatment Group B- HFCC and Cough Assist	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Amyotrophic Lateral Sclerosis

RecruitingPhase 1/2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ashraf Elsayegh, MD, FCCP principal investigator

Cedars-Sinai Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing High Frequency Chest Compression Device (HFCC) and Cough Assist in people with Amyotrophic Lateral Sclerosis, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02682030.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.