NCT05744310

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Accepted

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.

Conditions

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Nervous System Diseases
• Spinal Cord Diseases
• Neurodegenerative Diseases
• TDP-43 Proteinopathies

Interventions

Type	Name	Description
DEVICE	Long term mechanical ventilation support	Patients that choose life prolonging treatment with long term mechanical ventilation support
DEVICE	No long term mechanical ventilation support	Patients that decline life prolonging treatment with long term mechanical ventilation support

Timeline

• Start date: 2023-04-21
• Primary completion: 2032-08-21
• Completion: 2032-08-21
• First posted: 2023-02-27
• Last updated: 2025-08-28

Locations

9 sites across 1 country: Norway