NCT05744310

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
77mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Apr 2023Aug 2032

First Submitted

Initial submission to the registry

January 30, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 21, 2023

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2032

Last Updated

August 28, 2025

Status Verified

October 1, 2024

Enrollment Period

9.3 years

First QC Date

January 30, 2023

Last Update Submit

August 22, 2025

Conditions

Amyotrophic Lateral SclerosisMotor Neuron DiseaseNervous System DiseasesSpinal Cord DiseasesNeurodegenerative DiseasesTDP-43 Proteinopathies

Keywords

Quality of lifeOverall quality of lifeHealth related quality of lifeDisease specific quality of lifeVentilation supportNon-invasive ventilation supportInvasive ventilation support

Outcome Measures

Primary Outcomes (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.

    At inclusion

  • 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.

    3 months after inclusion

  • 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.

    9 months after inclusion

  • 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.

    15 months after inclusion

  • 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.

    21 months after inclusion

Secondary Outcomes (25)

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

    At inclusion

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

    3 months after inclusion

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

    9 months after inclusion

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

    15 months after inclusion

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

    21 months after inclusion

  • +20 more secondary outcomes

Study Arms (2)

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

ACTIVE COMPARATOR
Device: Long term mechanical ventilation support

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

ACTIVE COMPARATOR
Device: No long term mechanical ventilation support

Interventions

Long term mechanical ventilation supportDEVICE

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

ALS patients that choose life prolonging treatment with LTMV and their families
No long term mechanical ventilation supportDEVICE

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

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

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Can communicate in Norwegian

You may not qualify if:

  • \. Potential participants with cognitive impairment or dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Nordland Hospital Bodø

Bodø, Nordland, 8005, Norway

RECRUITING

Sørlandet Hospital Trust

Kristiansand, Vest Agder, Norway

RECRUITING

Haukeland University Hospital

Bergen, Norway

RECRUITING

Akershus University Hospital

Lørenskog, Norway

RECRUITING

Oslo University Hospital

Oslo, Norway

RECRUITING

Østfold Hospital Kalnes

Sarpsborg, 1714, Norway

NOT YET RECRUITING

Stavanger University Hospital

Stavanger, Norway

RECRUITING

Universitetssykehuset Nord-Norge

Tromsø, Norway

RECRUITING

St. Olavs Hospital

Trondheim, Norway

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral SclerosisMotor Neuron DiseaseNervous System DiseasesSpinal Cord DiseasesNeurodegenerative DiseasesTDP-43 Proteinopathies

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ole-Bjørn Tysnes

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ole-Bjørn Tysnes

CONTACT

+ 47 55975063ole-bjorn.tysnes@helse-bergen.no

Tale Litlere Bjerknes

CONTACT

+47 55975045tale.litlere.bjerknes@helse-bergen.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 27, 2023

Study Start

April 21, 2023

Primary Completion (Estimated)

August 21, 2032

Study Completion (Estimated)

August 21, 2032

Last Updated

August 28, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

NO(9)