NCT07071935 · University of Pennsylvania
A Pilot Randomized Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)
(EVENT ALS)
What this study is about
Amyotrophic lateral sclerosis (ALS) is a disease that causes weakness of the muscles of the body. The disease can eventually lead to severe breathing problems, which is the most common cause of death from ALS. The treatment for breathing is non-invasive ventilation (NIV). It is a machine that helps a person breathe by pushing air in and out of their lungs through a mask worn over the face.
View original scientific description
Amyotrophic lateral sclerosis (ALS) is a disease that causes weakness of the muscles of the body. The disease can eventually lead to severe breathing problems, which is the most common cause of death from ALS. The treatment for breathing is non-invasive ventilation (NIV). It is a machine that helps a person breathe by pushing air in and out of their lungs through a mask worn over the face. Research has shown that NIV can improve the quality of life and survival of someone with ALS.
Interventions
DEVICE
Non-invasive ventilation
Non-invasive ventilation will be started earlier than usual respiratory care guidelines for ALS in the United States.
Primary outcome measures
Time to first use of non-invasive ventilation
Time frame: From enrollment to end of follow-up at approximately 1 year
Number of days between randomization to first recorded overnight usage of non-invasive ventilation according to ventilation device data download.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosed with ALS using the Gold Coast Criteria within the last 6 months
- Age ≥18 years
- Willingness and ability to participate in study procedures
- Provision of signed and dated informed consent form
Exclusion criteria
- Current or prior or recommended/prescribed use of NIV including: i) bi-level positive pressure ventilation, such as a respiratory assist device or home ventilator ii) Current or prior use of continuous positive airway pressure, or "CPAP" therapy 2. Forced vital capacity \<50% of predicted normal 3. Maximal inspiratory pressure \> -60 cmH2O (eg, -50 or -40 cmH2O would be excluded) 4. Chronic use of supplemental oxygen at any part of the day 5. Enrollment in hospice 6. Current tracheostomy 7. Prior history of sleep apnea where non-invasive ventilation was used or recommended 8. Thoracic, abdominal, facial or ophthalmic surgery in the prior 6 weeks 9. Coughing up blood 10. Myocardial infarction in the previous 4 weeks 11. Absolute contr
Where
- Hershey, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphi, Pennsylvania
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations