Disease: ALS
Type of study: Interventional trial
Coordinating investigators: Tale L. Bjerknes & Ole-Bjørn Tysnes
Study director: Ole-Bjørn Tysnes
Background: The physical and psychological suffering of individuals with ALS is immense. Moreover, the lack of neuroprotective treatment and high level of disability means that the direct and indirect costs per patient are substantial and higher than for any other neurological illness. The economic burden of ALS in the USA is estimated to be 279-472 million dollars per year. For a patient depending on tracheostomy invasive ventilation (TIV) in Norway, it is estimated that the cost of care would be more than 5 million NOK annually. The use of TIV varies substantially between countries. In England it is rarely used, while in Japan, 29,3% of patients receive this treatment. In Europe and USA, the use varies from 5-10%. In Norway, 6,7% of male patients and 3,7% of female patients received TIV between 2002 and 2007. Data from the National Registry for Long-Term Mechanical Ventilation (LTMV) showed that in 2017, there were 32 ALS patients treated with TIV and 81 using non-invasive ventilation (NIV). In the period 2015-2020, 256 ALS patients started LTMV. Survival of ALS patients receiving TIV varies from 8 to 89 months, probably reflecting the different countries’ medical practices, organisation of care, cultural differences, and economic considerations.
Primary objective: In the present study, the aim is to increase the knowledge on how life-sustaining ventilator support with NIV or TIV affects the quality of life (QoL) in ALS patients, life partners and children, in Norway. The results from the study may provide crucial information for clinicians and patients on one of the most difficult ethical issues of ALS treatment. We anticipate that this information will facilitate a shared decision-making process, weighing benefits and disadvantages in a wider perspective.
Design: The ALS LTMV study is an observational clinical trial, where the quality of life will be assessed in ALS patients receiving NIV or TIV.
Primary endpoint: The HRQOL, global QoL and disease specific QoL in ALS patients before and after the introduction of life sustaining LTMV.
Status: During 2022, funding was secured, and new research nurses were added to the team, as well as participating hospitals. The study has started in 2023. Currently Haukeland University Hospital, and Oslo University Hospital, Ullevål are including patients.
Participating centres
- Haukeland University Hospital, Bergen
- Akershus University Hospital, Lørenskog
- Oslo University Hospital, Oslo
- Olav’s University Hospital, Trondheim
- Stavanger University Hospital, Stavanger
- University Hospital of North Norway, Tromsø
- Vestfold Hospital Trust, Tønsberg
- Innlandet Hospital, Lillehammer
- Nordland Hospital Trust, Bodø
- Sørlandet Hospital Trust Kristiansand
Funding
- KLINBEFORSK
- The Research Council of Norway, Neuro-SysMed
- Haukeland University Hospital
- The University of Bergen
- Participating hospitals