Actively Recruiting
Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families
Led by Haukeland University Hospital · Updated on 2025-08-28
200
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Haukeland University Hospital
Lead Sponsor
O
Oslo University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Amyotrophic lateral sclerosis ALS is a severe and rapidly progressing nervous system disease with an average survival of two to three years after diagnosis. Patients experience significant physical and psychological challenges, and apart from the drug Riluzole, effective treatments are lacking. This study aims to understand how life-sustaining ventilation support, either non-invasive or with tracheostomy, impacts the quality of life of ALS patients, their partners, and children, addressing a difficult ethical issue in ALS care. Participants are divided into two groups those who choose life-prolonging treatment with long-term mechanical ventilation support and those who decline such treatment. The study involves a longitudinal questionnaire approach conducted in Norway, measuring overall, health-related, and disease-specific quality of life over time. Assessments occur at inclusion and then every three months up to 21 months. Throughout the study, ALS patients, their partners, and children complete various quality of life questionnaires, including the Quality of Life Scale, EQ-5D-5L, ALS-specific scales, and caregiver burden surveys. Researchers monitor changes in these assessments to understand the effects of ventilation support. The study is sponsored by Haukeland University Hospital and includes participants aged 8 years and older, with data collection planned until 2032.
CONDITIONS
Brief Title
Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A clinical diagnosis of probable ALS according to the revised El Escorial criteria
- Illness progression leading the consulting physician to offer treatment with long-term mechanical ventilation support
- Ability to communicate in Norwegian
- Partners of ALS patients meeting the above criteria
- Children aged 8 years or older with a parent who has ALS and meets the above criteria
You will not qualify if you...
- Cognitive impairment or dementia in patients, partners, or children of ALS patients
- Inability to communicate in Norwegian
- Age below 8 years for children participating
- Not meeting diagnostic or disease progression criteria for ALS patients
- Not being a partner or child of an eligible ALS patient
Research Team
O
Ole-Bjørn Tysnes
T
Tale Litlere Bjerknes
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here