Amyotrophic Lateral Sclerosis study: Non-invasive ventilation
Official title A Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)
ClinicalTrials.gov ID: NCT07071935
What this study is testing
- What it's testing
- The study wants to see if starting NIV early is doable and to collect data that could guide a larger trial. It will also look at how early NIV affects breathing, symptoms, and who might not use it well.
- Who it's for
- Adults with amyotrophic lateral sclerosis who are not yet required by insurance to use NIV but are at risk of breathing problems in the next six months.
- What's involved
- Participants will be screened with a prediction tool and then randomly assigned to start NIV early or receive usual care. Those in the NIV group will use a mask that pushes air in and out of the lungs, while the usual care group will start NIV later if needed. The study will track breathing tests, symptoms, and other health measures.
- Time commitment
- The trial lasts about 12 months, with regular clinic visits and breathing tests to monitor progress and safety.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Current or prior or recommended/prescribed use of NIV including: i) bi-level positive pressure ventilation, such as a respiratory assist device or...
- Forced vital capacity \<50% of predicted normal
- Maximal inspiratory pressure \> -60 cmH2O (eg, -50 or -40 cmH2O would be excluded)
- Chronic use of supplemental oxygen at any part of the day
- Enrollment in hospice
- Current tracheostomy
See the full eligibility 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
- 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...
- Forced vital capacity \<50% of predicted normal
- Maximal inspiratory pressure \> -60 cmH2O (eg, -50 or -40 cmH2O would be excluded)
- Chronic use of supplemental oxygen at any part of the day
- Enrollment in hospice
- Current tracheostomy
- Prior history of sleep apnea where non-invasive ventilation was used or recommended
- Thoracic, abdominal, facial or ophthalmic surgery in the prior 6 weeks
- Coughing up blood
- Myocardial infarction in the previous 4 weeks
- Absolute contraindication to NIV, which includes lethargy, obtundation, facial fractures, active pneumothorax, and airway obstruction (such as a tumor)
- Presence of cognitive dysfunction that would impair ability to complete study procedures, as determined by neurology attending physician
The study team makes the final eligibility decision.
Where it is enrolling
- Hershey, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Philadelphi, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hershey, Pennsylvania, United States; Philadelphia, Pennsylvania, United States; Philadelphi, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.