Amyotrophic Lateral SclerosisALSACNCT04947436
ALS and Airway Clearance (ALSAC) Therapy
A study testing High Frequency Chest Wall Oscillation and Mechanical insufflation/exsufflation in people with Amyotrophic Lateral Sclerosis and Respiratory Muscle Weakness, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Patients will receive one of three respiratory therapy interventions for airway clearance assistance: 1) High frequency chest wall oscillation (HFCWO) and mechanical insufflation/exsufflation (MIE), 2) HFCWO or 3) MIE. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Respiratory Muscle Weakness
- What is being tested?
- High Frequency Chest Wall Oscillation and Mechanical insufflation/exsufflation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2012to 17 Sep 2017
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 and above,
- Probable or definite ALS diagnosis,
- Peak Cough Flow of <160L/min or complain of issues clearing airway secretions
- Caregiver must also consent to participate
Who cannot join
- Current use of HFCWO or MIE
- Tracheostomy
- Congestive heart failure
- All contraindications for the HFCWO
- Head and/or neck injury that has not been stabilized;
- Active hemorrhage with hemodynamic instability;
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- Uncontrolled hypertension;
- Active or recent gross hemoptysis; and
- All contraindications for the MIE
- History of bullous emphysema;
- Known susceptibility to pneumothorax;
- Pneumomediastinum; and
- Recent barotrauma
- Frontal Temporal Dementia (FTD) - suspected or diagnosed . FTD is a form of dementia found in about 20% of Familial ALS. This dementia interferes with the ability to follow commands and follow through with therapies due to forgetfulness.
- Patients not able to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health San Antonio
San Antonio, Texas, 78229
About this study
Official title: ALS and Airway Clearance (ALSAC) Is There a Best Therapy for Airway Clearance in Patients With ALS
Patients will receive one of three respiratory therapy interventions for airway clearance assistance: 1) High frequency chest wall oscillation (HFCWO) and mechanical insufflation/exsufflation (MIE), 2) HFCWO or 3) MIE. The study period will be six months and include three clinic visits, baseline and follow-up visits at 3 and 6 months, and 6 monthly home visits by the respiratory therapist.
Read the detailed description
The proposed project includes both the HFCWO and MIE and will capitalize on the specific goals of each therapy and address the problem as a whole rather than piece-meal. The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many patients diagnosed with ALS are unable to expel the secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows to pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx. The MIE, a noninvasive therapy, removes secretions in patients who have an ineffective cough because the peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions. Logically, the two mechanisms of action of these devices should work synergistically to produce effective airway clearance to keep the lungs clear, healthy and reduce the risk of infections from stagnant secretions. Respiratory infections are especially serious for patients with ALS because the patient is not able to recuperate from infections as quickly as a person without ALS. The objective is to determine if changing the use of existing respiratory therapy devices can improve the physical and psychosocial health and quality of life for patients diagnosed with ALS and caregivers.
- Being tested
- High Frequency Chest Wall Oscillation, Mechanical insufflation/exsufflation
- Keywords
- Amyotrophic Lateral Sclerosis, Airway Clearance, Mechanical Insufflation Exsufflation, High Frequency Chest Wall Compression Oscillation
- 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 Wall OscillationDevice
Also called "The Vest"
The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx.
Mechanical insufflation/exsufflationDevice
Also called Cough Assist
A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions.
| Study group | Role | What they receive |
|---|---|---|
| High Frequency Chest Wall Oscillation | Active comparator | Not described Receives: Device: High Frequency Chest Wall Oscillation |
| Mechanical insufflation/ exsufflation | Active comparator | Not described Receives: Device: Mechanical insufflation/exsufflation |
| High Frequency Chest Wall Oscillation and Mechanical insufflation/ exsufflation | Active comparator | Not described Receives: Device: High Frequency Chest Wall Oscillation; Device: Mechanical insufflation/exsufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Complications Severity
A 9-item instrument will be used to record change from baseline to 6 months in respiratory complications. These are scored on a scale from best (no complications) to worst (death due to respiratory complications) throughout the study period. Scores range from 0-9 with a score of a 9 indicating no complications.
Measured: Baseline to 6 months
Secondary outcomes (1)
Patient Global Impression of Change (PGIC)
This outcome is assessed and recorded as a number from 1-5 with 1 indicating the worst outcome (markedly worse) and 5 indicating best outcome (markedly better) since starting the study.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start25 Jan 2012
- Primary completion21 Sep 2016
- Study completion17 Sep 2017
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 The University of Texas Health Science Center at San AntonioThe 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
- Model description
- A single-blind parallel group design in which 60 patients with probable or definite ALS will be randomized equally into three groups (20 per group) over a period of 12 months
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ALS Association
- Responsible party
- Sponsor
- Investigators
- Donna Gardner, DrPH, Principal investigator, University of Texas Health San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947436
- Sponsor's protocol ID
- HSC20120075
- Acronym
- ALSAC
- Status last verified
- Oct 2021
- First submitted
- 23 Jun 2021
- Last updated
- 4 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified participant data will be available in result publication and in summary result reporting in ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALS and Airway Clearance (ALSAC) Is There a Best Therapy for Airway Clearance in Patients With ALS
- ClinicalTrials.gov ID
- NCT04947436
- Acronym / sponsor ID
- ALSAC / HSC20120075
- Keywords
- Amyotrophic Lateral Sclerosis, Airway Clearance, Mechanical Insufflation Exsufflation, High Frequency Chest Wall Compression Oscillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- ALS Association
- Study start
- 25 Jan 2012 (actual)
- Primary completion
- 21 Sep 2016 (actual)
- Study completion
- 17 Sep 2017 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Posted 4 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will receive one of three respiratory therapy interventions for airway clearance assistance: 1) High frequency chest wall oscillation (HFCWO) and mechanical insufflation/exsufflation (MIE), 2) HFCWO or 3) MIE. The study period will be six months and include three clinic visits, baseline and follow-up visits at 3 and 6 months, and 6 monthly home visits by the respiratory therapist.
Detailed description
The proposed project includes both the HFCWO and MIE and will capitalize on the specific goals of each therapy and address the problem as a whole rather than piece-meal. The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many patients diagnosed with ALS are unable to expel the secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows to pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx. The MIE, a noninvasive therapy, removes secretions in patients who have an ineffective cough because the peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions. Logically, the two mechanisms of action of these devices should work synergistically to produce effective airway clearance to keep the lungs clear, healthy and reduce the risk of infections from stagnant secretions. Respiratory infections are especially serious for patients with ALS because the patient is not able to recuperate from infections as quickly as a person without ALS. The objective is to determine if changing the use of existing respiratory therapy devices can improve the physical and psychosocial health and quality of life for patients diagnosed with ALS and caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- A single-blind parallel group design in which 60 patients with probable or definite ALS will be randomized equally into three groups (20 per group) over a period of 12 months
| Arm | Type | Receives |
|---|---|---|
| High Frequency Chest Wall Oscillation | Active comparator | Device: High Frequency Chest Wall Oscillation |
| Mechanical insufflation/ exsufflation | Active comparator | Device: Mechanical insufflation/exsufflation |
| High Frequency Chest Wall Oscillation and Mechanical insufflation/ exsufflation | Active comparator | Device: High Frequency Chest Wall Oscillation, Device: Mechanical insufflation/exsufflation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21 and above,
- Probable or definite ALS diagnosis,
- Peak Cough Flow of <160L/min or complain of issues clearing airway secretions
- Caregiver must also consent to participate
Key exclusion criteria (15 listed)
- Current use of HFCWO or MIE
- Tracheostomy
- Congestive heart failure
- All contraindications for the HFCWO
- Head and/or neck injury that has not been stabilized;
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 Wall OscillationAlso: "The Vest"The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx. | Device | High Frequency Chest Wall Oscillation, High Frequency Chest Wall Oscillation and Mechanical insufflation/ exsufflation |
| Mechanical insufflation/exsufflationAlso: Cough AssistA noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions. | Device | High Frequency Chest Wall Oscillation and Mechanical insufflation/ exsufflation, Mechanical insufflation/ exsufflation |
Primary outcome
Respiratory Complications Severity
Time frame: Baseline to 6 months
A 9-item instrument will be used to record change from baseline to 6 months in respiratory complications. These are scored on a scale from best (no complications) to worst (death due to respiratory complications) throughout the study period. Scores range from 0-9 with a score of a 9 indicating no complications.
1 secondary outcome
Patient Global Impression of Change (PGIC)
Time frame: Baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified participant data will be available in result publication and in summary result reporting in ClinicalTrials.gov
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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.
Donna Gardner, DrPH principal investigator
University of Texas Health San Antonio
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 Wall Oscillation and Mechanical insufflation/exsufflation in people with Amyotrophic Lateral Sclerosis and Respiratory Muscle Weakness, run by The University of Texas Health Science Center at San Antonio 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 15 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 4 Nov 2021. 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 4 Nov 2021). 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?
Respiratory Complications Severity (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2021.