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RecruitingNCT05744310ALS-LTMVUpdated Sep 21, 2026

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

An interventional study of Long term mechanical ventilation support and No long term mechanical ventilation support in Amyotrophic Lateral Sclerosis, Motor Neuron Disease and Nervous System Diseases, sponsored by Haukeland University Hospital. Recruiting at 9 sites in Norway. Open to participants aged 8 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Haukeland University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
8 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

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
03

In context

Amyotrophic Lateral Sclerosis

978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.

This study's planned enrollment of 200 is above the median of 38 across 662 interventional studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Browse Haukeland University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    ALS patients that choose life prolonging treatment with LTMV and their families

    Device: Long term mechanical ventilation support

  • Active comparator
    ALS patients that decline life prolonging treatment with LTMV and their families

    Device: No long term mechanical ventilation support

Interventions

  • DeviceLong term mechanical ventilation support

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

  • DeviceNo long term mechanical ventilation support

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 21 months after inclusion

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 21 months after inclusion

07

Study locations

8 of 9 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2023 (actual). Primary completion is estimated for Aug 2032, 112 months after the start.

Of 134 non-industry interventional studies with no phase under Amyotrophic Lateral Sclerosis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 60. This study's planned 112 months is above that.

Counting every sponsor, half of 154 studies reached it within 35 months; a quarter within 23 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2023
First posted
Feb 27, 2023
StartActual
Apr 21, 2023
Primary completionEst.
Aug 21, 2032
CompletionEst.
Aug 21, 2032
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
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
Responsible party
Sponsor
First posted
Feb 27, 2023
Start date
Apr 21, 2023
Primary completion
Aug 21, 2032 (estimated)
Completion
Aug 21, 2032 (estimated)
Last update
Sep 21, 2026

Study contacts

Ole-Bjørn Tysnes
Contact
ole-bjorn.tysnes@helse-bergen.no
+ 47 55975063
Tale Litlere Bjerknes
Contact
tale.litlere.bjerknes@helse-bergen.no
+47 55975045
Ole-Bjørn Tysnes
principal investigator · Haukeland University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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