Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency (NCT06286917) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency
Finland120 participantsStarted 2024-03-05
Plain-language summary
This research will study whether noninvasive ventilation (NIV) used to treat chronic respiratory insufficiency in patients with amyotrophic lateral sclerosis (ALS) can be initiated as successfully in the outpatient setting as in the conventional inpatient setting, and what the costs of these alternative initiation methods are.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ALS diagnosed by a neurology and
* chronic respiratory insufficiency or significant respiratory muscle weakness caused by ALS
Exclusion Criteria:
* impaired cognition to give informed consent to participation
* contraindication to NIV therapy
* another severe disease with a prognosis of less than one year
* ventilation via an artificial airway, tracheostomy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
NIV usage hours according to different initiation locations in patients with ALS
Timeframe: 5 years
2
Compliance with NIV according to NIV initiation setting in patients with ALS
Timeframe: 5 years
3
Decrease in blood carbon dioxide levels in patients with ALS depending on the place of NIV initiation.