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Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families

Study acronym: ALS-LTMV
StatusRecruiting
PhaseNot applicable
Started2023-04-21
View on ClinicalTrials.gov ↗

Amendment history

2025-08-22
minor
Study Status, Sponsor/Collaborators, Contacts/Locations v7
Study sitesdetails revised at 2 of 9 sites
Collaborators5 to 8 entries
Nordland Hospital, Bodø Hospital of Southern Norway Kristiansand Østfold Hospital Kalnes
2025-05-23
minor
Study Status, Contacts/Locations v6
Study sites7→9
2025-03-26
minor
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Contacts/Locations v5
Study sites6→7
Collaborators5 entries, reordered
2024-10-28
minor
Study Status, Contacts/Locations v4
Study sitesdetails revised at 2 of 6 sites
2024-03-04
minor
Study Status, Contacts/Locations v3
Study sitesdetails revised at 2 of 6 sites
Show 2 earlier versions
2023-09-18
minor
Study Status, Contacts/Locations v2
Start dateestimated 2023-04-12→confirmed 2023-04-21
Study sitesdetails revised at 1 of 6 sites
2023-04-11
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2023-03-06→2023-04-12
Study sitesdetails revised at 6 of 6 sites
2023-02-21
minor
Original filing
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.
Trial Details
NCT Number NCT05744310
Lead Sponsor Haukeland University Hospital
Collaborators: Oslo University Hospital, University Hospital, Akershus, Helse Stavanger HF, University Hospital of North Norway, St. Olavs Hospital, Nordland Hospital, Bodø, Hospital of Southern Norway Kristiansand, Østfold Hospital Kalnes
Conditions Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Nervous System Diseases, Spinal Cord Diseases, Neurodegenerative Diseases, TDP-43 Proteinopathies
Enrollment 200 participants
Start Date 2023-04-21
Primary Completion 2032-08-21 (estimated)
Study Completion 2032-08-21 (estimated)
Updated on ClinicalTrials.gov 2026-09-21