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Amyotrophic Lateral SclerosisALS-LTMVNCT05744310

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

A study testing Long term mechanical ventilation support and No long term mechanical ventilation support in people with Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by Haukeland University Hospital at 9 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 8 years and olderHealthy volunteers can take part
What is being tested?
Long term mechanical ventilation support and No long term mechanical ventilation support
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
9 sitesNorway
Study dates
21 Apr 2023to 21 Aug 2032
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • A clinical diagnosis of probable ALS according to the revised El Escorial criteria
  • Progression of the illness leading the consulting physician to offer treatment with LTMV
  • Can communicate in Norwegian
  • Partner of a patient with ALS with progression of the illness leading the consulting physician to offer treatment with LTMV
  • Can communicate in Norwegian
  • 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
Show all 9Show fewer
  • Can communicate in Norwegian
  • Exclusion criteria for patients, partners and children of ALS patients:
  • 1. Potential participants with cognitive impairment or dementia.

Who cannot join

None listed.

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ole-Bjørn Tysnes contact

+ 47 55975063

ole-bjorn.tysnes@helse-bergen.no

Tale Litlere Bjerknes contact

+47 55975045

tale.litlere.bjerknes@helse-bergen.no

9 sites in 1 country

Norway9 sites, 9 recruiting

  • Haukeland University Hospital

    Bergen

    Ole-Bjørn Tysnes, +4755975063, ole-bjorn.tysnes@helse-bergen.no

    Recruiting

  • Nordland Hospital Bodø

    Bodø, Nordland, 8005

    Ane Sjulstad, MD, 75571000 ext. +47, Ane.Skaare.Sjulstad@nordlandssykehuset.no

    Recruiting

  • Sørlandet Hospital Trust

    Kristiansand, Vest Agder

    Hildegunn Øverlie, MD, 38073000 ext. + 47, hildegunn.overlie@sshf.no

    Recruiting

  • Akershus University Hospital

    Lørenskog

    Ola Nakken

    Ola Nakken

    Recruiting

  • Oslo University Hospital

    Oslo

    Angelina Maniaol

    Angelina Maniaol

    Recruiting

  • Østfold Hospital Kalnes

    Sarpsborg, 1714

    Sophie Cranner Seip, MD, 69 86 00 00 ext. +47, Sophie.Cranner.Seip@so-hf.no

    Not yet recruiting

  • Stavanger University Hospital

    Stavanger

    Katrin Ruth Schlüter

    Katrin Ruth Schlüter

    Recruiting

  • Universitetssykehuset Nord-Norge

    Tromsø

    Agnethe Eltoft, MD, +4777627075, agnethe.eltoft@unn.no

    Monica Vold, MD, monica.linnea.vold@unn.no

    Recruiting

  • St. Olavs Hospital

    Trondheim

    Eivind Brønstad, MD PhD

    Eivind Brønstad, MD PhD

    Recruiting

Other trials in Norway

About this study

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.

Being tested
Long term mechanical ventilation support, No long term mechanical ventilation support
Keywords
Quality of life, Overall quality of life, Health related quality of life, Disease specific quality of life, Ventilation support, Non-invasive ventilation support, Invasive ventilation support
Medical subject headings
Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Nervous System Diseases, Spinal Cord Diseases, Neurodegenerative Diseases, TDP-43 Proteinopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Long term mechanical ventilation supportDevice

    Patients that choose life prolonging treatment with long term mechanical ventilation support

  • No long term mechanical ventilation supportDevice

    Patients that decline life prolonging treatment with long term mechanical ventilation support

Study groups in NCT05744310
Study groupRoleWhat they receive
ALS patients that choose life prolonging treatment with LTMV and their familiesActive comparatorNot described
Receives: Device: Long term mechanical ventilation support
ALS patients that decline life prolonging treatment with LTMV and their familiesActive comparatorNot described
Receives: Device: No long term mechanical ventilation support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall quality of life assessed by the "Quality of Life Scale"

    "Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.

    Measured: At inclusion

  2. Overall quality of life assessed by the "Quality of Life Scale"

    "Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.

    Measured: 3 months after inclusion

  3. Overall quality of life assessed by the "Quality of Life Scale"

    "Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.

    Measured: 9 months after inclusion

  4. Overall quality of life assessed by the "Quality of Life Scale"

    "Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.

    Measured: 15 months after inclusion

  5. Overall quality of life assessed by the "Quality of Life Scale"

    "Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.

    Measured: 21 months after inclusion

Secondary outcomes (25)

  1. Health-related quality of life assessed by the "EQ-5D-5L"

    "EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.

    Measured: At inclusion

  2. Health-related quality of life assessed by the "EQ-5D-5L"

    "EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.

    Measured: 3 months after inclusion

  3. Health-related quality of life assessed by the "EQ-5D-5L"

    "EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.

    Measured: 9 months after inclusion

  4. Health-related quality of life assessed by the "EQ-5D-5L"

    "EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.

    Measured: 15 months after inclusion

  5. Health-related quality of life assessed by the "EQ-5D-5L"

    "EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.

    Measured: 21 months after inclusion

  6. Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"

    "ALSAQ-5" score (range 0-100), with 0 reflecting the best health state

    Measured: At inclusion

  7. Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"

    "ALSAQ-5" score (range 0-100), with 0 reflecting the best health state

    Measured: 3 months after inclusion

  8. Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"

    "ALSAQ-5" score (range 0-100), with 0 reflecting the best health state

    Measured: 9 months after inclusion

  9. Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"

    "ALSAQ-5" score (range 0-100), with 0 reflecting the best health state

    Measured: 15 months after inclusion

  10. Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"

    "ALSAQ-5" score (range 0-100), with 0 reflecting the best health state

    Measured: 21 months after inclusion

  11. Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"

    "Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.

    Measured: At inclusion

  12. Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"

    "Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.

    Measured: 3 months after inclusion

  13. Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"

    "Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.

    Measured: 9 months after inclusion

  14. Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"

    "Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.

    Measured: 15 months after inclusion

  15. Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"

    "Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.

    Measured: 21 months after inclusion

  16. Health-related quality of life assessed by "Kidsscreen-27"

    "Kidsscreen-27" score where mean (±SD) scores of 50 ± 10 define normality for children and adolescents aged 8-18 years across Europe. Higher scores indicate a better health-related quality of life.

    Measured: At inclusion

  17. Health-related quality of life assessed by "Kidsscreen-27"

    "Kidsscreen-27" score where mean (±SD) scores of 50 ± 10 define normality for children and adolescents aged 8-18 years across Europe. Higher scores indicate a better health-related quality of life.

    Measured: 3 months after inclusion

  18. Health-related quality of life assessed by "Kidsscreen-27"

    "Kidsscreen-27" score where mean (±SD) scores of 50 ± 10 define normality for children and adolescents aged 8-18 years across Europe. Higher scores indicate a better health-related quality of life.

    Measured: 9 months after inclusion

  19. Health-related quality of life assessed by "Kidsscreen-27"

    "Kidsscreen-27" score where mean (±SD) scores of 50 ± 10 define normality for children and adolescents aged 8-18 years across Europe. Higher scores indicate a better health-related quality of life.

    Measured: 15 months after inclusion

  20. Health-related quality of life assessed by "Kidsscreen-27"

    "Kidsscreen-27" score where mean (±SD) scores of 50 ± 10 define normality for children and adolescents aged 8-18 years across Europe. Higher scores indicate a better health-related quality of life.

    Measured: 21 months after inclusion

  21. Caregiver burden assessed by "Zarit Burden Interview"

    "Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).

    Measured: At inclusion

  22. Caregiver burden assessed by "Zarit Burden Interview"

    "Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).

    Measured: 3 months after inclusion

  23. Caregiver burden assessed by "Zarit Burden Interview"

    "Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).

    Measured: 9 months after inclusion

  24. Caregiver burden assessed by "Zarit Burden Interview"

    "Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).

    Measured: 15 months after inclusion

  25. Caregiver burden assessed by "Zarit Burden Interview"

    "Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).

    Measured: 21 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2023
  2. Study start21 Apr 2023
  3. Primary completion21 Aug 2032 (estimated)
  4. Study completion21 Aug 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05744310
Sponsor's protocol ID
492102
Acronym
ALS-LTMV
Status last verified
Sep 2026
First submitted
30 Jan 2023
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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