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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 months
Participants either receive long term mechanical ventilation support or decline this treatment as part of their care.
Assessments at inclusion, and at 3, 9, 15, and 21 months after inclusion
Trial Site Locations
Total: 9 locations
1
Nordland Hospital Bodø
Bodø, Nordland, Norway, 8005
Actively Recruiting
2
Sørlandet Hospital Trust
Kristiansand, Vest Agder, Norway
Actively Recruiting
3
Haukeland University Hospital
Bergen, Norway
Actively Recruiting
4
Akershus University Hospital
Lørenskog, Norway
Actively Recruiting
5
Oslo University Hospital
Oslo, Norway
Actively Recruiting
6
Østfold Hospital Kalnes
Sarpsborg, Norway, 1714
Not Yet Recruiting
7
Stavanger University Hospital
Stavanger, Norway
Actively Recruiting
8
Universitetssykehuset Nord-Norge
Tromsø, Norway
Actively Recruiting
9
St. Olavs Hospital
Trondheim, Norway
Actively Recruiting
Research Team
O
Ole-Bjørn Tysnes
T
Tale Litlere Bjerknes
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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