NCT05744310 Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families
| NCT ID | NCT05744310 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Haukeland University Hospital |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-04-21 |
| Primary Completion | 2032-08-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-04-21 with a primary completion date of 2032-08-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system. The average survival from the time of diagnosis is two to three years. The patient physical and psychological sufferings in ALS are immense, and apart from Riluzole, there is no effective treatment. Care of advanced ALS have an estimated cost of 4-8 million NOK per year. Perhaps the most challenging topic of ALS care is the decision to extend ventilation support into the stages of disease that require treatment both during day and night. In these cases, treatment is clearly life-sustaining and although quality of life may be maintained, the burden of caregiving imposed upon family or health care workers is huge, regardless of tracheostomy (TIV) or non-invasive (NIV) modality. The present study is a longitudinal questionnaire study in Norway measuring overall quality of life, health-related quality of life, and disease-specific quality of life in ALS patients, partners and children before and after the introduction of life sustaining ventilation support. The investigators aim to increase the knowledge on how life-sustaining ventilation support with NIV or TIV affects the quality of life in ALS patients, life partners and children. The results from the study may provide crucial information for clinicians and patients on one of the most difficult ethical issues of ALS treatment. The investigators anticipate that this information will facilitate a shared decision making processes, weighing benefits and disadvantages in a wider perspective.
Eligibility 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.
Contact & Investigator
Ole-Bjørn Tysnes
PRINCIPAL INVESTIGATOR
Haukeland University Hospital
Frequently Asked Questions
Who can join the NCT05744310 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05744310 currently recruiting?
Yes, NCT05744310 is actively recruiting participants. Contact the research team at ole-bjorn.tysnes@helse-bergen.no for enrollment information.
Where is the NCT05744310 trial being conducted?
This trial is being conducted at Bodø, Norway, Kristiansand, Norway, Bergen, Norway, Lørenskog, Norway and 5 additional locations.
Who is sponsoring the NCT05744310 clinical trial?
NCT05744310 is sponsored by Haukeland University Hospital. The principal investigator is Ole-Bjørn Tysnes at Haukeland University Hospital. The trial plans to enroll 200 participants.
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