Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families (ALS-LTMV)

August 22, 2025 updated by: Haukeland University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Norway
      • Bergen, Norway
      • Lørenskog, Norway
        • Recruiting
        • Akershus University Hospital
        • Principal Investigator:
          • Ola Nakken
        • Contact:
          • Ola Nakken
      • Oslo, Norway
        • Recruiting
        • Oslo University Hospital
        • Principal Investigator:
          • Angelina Maniaol
        • Contact:
          • Angelina Maniaol
      • Sarpsborg, Norway, 1714
        • Not yet recruiting
        • Østfold Hospital Kalnes
        • Contact:
      • Stavanger, Norway
        • Recruiting
        • Stavanger University Hospital
        • Principal Investigator:
          • Katrin Ruth Schlüter
        • Contact:
          • Katrin Ruth Schlüter
      • Tromsø, Norway
        • Recruiting
        • Universitetssykehuset Nord-Norge
        • Contact:
        • Contact:
        • Principal Investigator:
          • Agnethe Eltoft, MD
        • Principal Investigator:
          • Monica Vold, MD
      • Trondheim, Norway
        • Recruiting
        • St. Olavs Hospital
        • Contact:
          • Eivind Brønstad, MD PhD
        • Principal Investigator:
          • Eivind Brønstad, MD PhD
    • Nordland
    • Vest Agder
      • Kristiansand, Vest Agder, Norway
        • Recruiting
        • Sørlandet Hospital Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: ALS patients that choose life prolonging treatment with LTMV and their families
Device: Long term mechanical ventilation support
Patients that choose life prolonging treatment with 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
Patients that decline life prolonging treatment with long term mechanical ventilation support

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall quality of life assessed by the "Quality of Life Scale"
Time Frame: At inclusion
"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"
Time Frame: 3 months after inclusion
"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"
Time Frame: 9 months after inclusion
"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"
Time Frame: 15 months after inclusion
"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"
Time Frame: 21 months after inclusion
"Quality of Life Scale" total score (range 16-112). Higher score indicates better quality of life.
21 months after inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health-related quality of life assessed by the "EQ-5D-5L"
Time Frame: At inclusion
"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.
At inclusion
Health-related quality of life assessed by the "EQ-5D-5L"
Time Frame: 3 months after inclusion
"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.
3 months after inclusion
Health-related quality of life assessed by the "EQ-5D-5L"
Time Frame: 9 months after inclusion
"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.
9 months after inclusion
Health-related quality of life assessed by the "EQ-5D-5L"
Time Frame: 15 months after inclusion
"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.
15 months after inclusion
Health-related quality of life assessed by the "EQ-5D-5L"
Time Frame: 21 months after inclusion
"EQ-5D-5L" index score and EQ-VAS score (range 0-100) where higher scores indicates better health-related quality of life.
21 months after inclusion
Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
Time Frame: At inclusion
"ALSAQ-5" score (range 0-100), with 0 reflecting the best health state
At inclusion
Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
Time Frame: 3 months after inclusion
"ALSAQ-5" score (range 0-100), with 0 reflecting the best health state
3 months after inclusion
Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
Time Frame: 9 months after inclusion
"ALSAQ-5" score (range 0-100), with 0 reflecting the best health state
9 months after inclusion
Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
Time Frame: 15 months after inclusion
"ALSAQ-5" score (range 0-100), with 0 reflecting the best health state
15 months after inclusion
Disease-specific quality of life assessed by "Amyotrophic lateral sclerosis assessment scale - 5 items (ALSAQ-5)"
Time Frame: 21 months after inclusion
"ALSAQ-5" score (range 0-100), with 0 reflecting the best health state
21 months after inclusion
Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
Time Frame: At inclusion
"Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.
At inclusion
Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
Time Frame: 3 months after inclusion
"Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.
3 months after inclusion
Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
Time Frame: 9 months after inclusion
"Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.
9 months after inclusion
Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
Time Frame: 15 months after inclusion
"Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.
15 months after inclusion
Health-related quality of life assessed by "Severe Respiratory Insufficiency Questionnaire"
Time Frame: 21 months after inclusion
"Severe Respiratory Insufficiency Questionnaire" score (range 0-100), with 100 reflecting the best health state.
21 months after inclusion
Health-related quality of life assessed by "Kidsscreen-27"
Time Frame: At inclusion
"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.
At inclusion
Health-related quality of life assessed by "Kidsscreen-27"
Time Frame: 3 months after inclusion
"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.
3 months after inclusion
Health-related quality of life assessed by "Kidsscreen-27"
Time Frame: 9 months after inclusion
"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.
9 months after inclusion
Health-related quality of life assessed by "Kidsscreen-27"
Time Frame: 15 months after inclusion
"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.
15 months after inclusion
Health-related quality of life assessed by "Kidsscreen-27"
Time Frame: 21 months after inclusion
"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.
21 months after inclusion
Caregiver burden assessed by "Zarit Burden Interview"
Time Frame: At inclusion
"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
At inclusion
Caregiver burden assessed by "Zarit Burden Interview"
Time Frame: 3 months after inclusion
"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
3 months after inclusion
Caregiver burden assessed by "Zarit Burden Interview"
Time Frame: 9 months after inclusion
"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
9 months after inclusion
Caregiver burden assessed by "Zarit Burden Interview"
Time Frame: 15 months after inclusion
"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
15 months after inclusion
Caregiver burden assessed by "Zarit Burden Interview"
Time Frame: 21 months after inclusion
"Zarit Burden Interview" total score (range 0-88 where a higher score indicates greater burden).
21 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Haukeland University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Oslo University Hospital
University Hospital of North Norway
Helse Stavanger HF
St. Olavs Hospital
University Hospital, Akershus
Nordland Hospital, Bodø
Hospital of Southern Norway Kristiansand
Østfold Hospital Kalnes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ole-Bjørn Tysnes, Haukeland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 21, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 21, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 492102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings