Impact of long-term ventilation support on ALS patients and their families
Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families
This study is testing how long-term breathing support affects the quality of life for people with ALS and their families.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 8 Years and up |
| Sex | All |
| Sponsor | Haukeland University Hospital Academic / other |
| Locations | 9 sites (Bodø, Nordland and 8 other locations) |
| Trial ID | NCT05744310 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of long-term mechanical ventilation support on the quality of life for patients with Amyotrophic Lateral Sclerosis (ALS) and their families. It involves a longitudinal questionnaire approach to assess overall, health-related, and disease-specific quality of life among ALS patients, their partners, and children. The study aims to understand the balance between life-sustaining treatment and the caregiving burden experienced by families. Participants will be recruited from various hospitals in Norway, focusing on those who can communicate in Norwegian.
Who should consider this trial
Good fit: Ideal candidates include ALS patients who are being considered for long-term mechanical ventilation support and their partners and children who can communicate in Norwegian.
Not a fit: Patients with cognitive impairment or dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into improving the quality of life for ALS patients and their families during advanced stages of the disease.
How similar studies have performed: While there have been studies on ALS care, this specific focus on long-term ventilation support and its impact on quality of life is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria for patients: 1. A clinical diagnosis of probable ALS according to the revised El Escorial criteria 2. Progression of the illness leading the consulting physician to offer treatment with LTMV 3. Can communicate in Norwegian Inclusion criteria for partners of ALS patients: 1. Partner of a patient with ALS with progression of the illness leading the consulting physician to offer treatment with LTMV 2. Can communicate in Norwegian Inclusion criteria for children: 1. Children from 8 years and older having a parent who suffers from ALS with progression of the illness leading the consulting physician to offer treatment with LTMV 2. Can communicate in Norwegian Exclusion criteria for patients, partners and children of ALS patients: 1\. Potential participants with cognitive impairment or dementia.
Where this trial is running
Bodø, Nordland and 8 other locations
- Nordland Hospital Bodø — Bodø, Nordland, Norway (Recruiting)
- Sørlandet Hospital Trust — Kristiansand, Vest Agder, Norway (Recruiting)
- Haukeland University Hospital — Bergen, Norway (Recruiting)
- Akershus University Hospital — Lørenskog, Norway (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- Østfold Hospital Kalnes — Sarpsborg, Norway (Not_yet_recruiting)
- Stavanger University Hospital — Stavanger, Norway (Recruiting)
- Universitetssykehuset Nord-Norge — Tromsø, Norway (Recruiting)
- St. Olavs Hospital — Trondheim, Norway (Recruiting)
Study contacts
- Principal investigator: Ole-Bjørn Tysnes — Haukeland University Hospital
- Study coordinator: Ole-Bjørn Tysnes
- Email: ole-bjorn.tysnes@helse-bergen.no
- Phone: + 47 55975063
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.