Using noninvasive ventilation for ALS patients with breathing difficulties
Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency
This study tests whether starting noninvasive ventilation at home can help ALS patients with breathing difficulties feel better compared to starting it in the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Tampere University Academic / other |
| Locations | 1 site (Tampere) |
| Trial ID | NCT06286917 on ClinicalTrials.gov |
What this trial studies
This research investigates the effectiveness of initiating noninvasive ventilation (NIV) for treating chronic respiratory insufficiency in patients with amyotrophic lateral sclerosis (ALS) in an outpatient setting compared to traditional inpatient methods. The study aims to evaluate the success rates of NIV initiation and analyze the associated costs of both approaches. By focusing on outpatient initiation, the research seeks to improve accessibility and convenience for patients requiring respiratory support.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with ALS who are experiencing chronic respiratory insufficiency or significant respiratory muscle weakness.
Not a fit: Patients with impaired cognition, severe comorbid conditions, or those requiring ventilation via an artificial airway will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the quality of life for ALS patients by providing effective respiratory support in a more accessible outpatient setting.
How similar studies have performed: While the approach of outpatient NIV initiation is being explored, similar studies have shown promising results in improving patient outcomes, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tampere
- Tampere University Hospital — Tampere, Finland (Recruiting)
Study contacts
- Study coordinator: Heidi A Rantala, MD, PhD
- Email: heidi.rantala@tuni.fi
- Phone: +3583311611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.