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

NCT ID: NCT05744310

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-21
• Study Completion Date: 2032-08-21

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Long term mechanical ventilation support

Intervention Type: DEVICE

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

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

Group Type: ACTIVE_COMPARATOR

No long term mechanical ventilation support

Intervention Type: DEVICE

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

Interventions

Long term mechanical ventilation support

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

Intervention Type: DEVICE

No long term mechanical ventilation support

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

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

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

1. Potential participants with cognitive impairment or dementia.

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Nordland Hospital, Bodø

UNKNOWN

Sponsor Role: collaborator

Hospital of Southern Norway Kristiansand

UNKNOWN

Sponsor Role: collaborator

Østfold Hospital Kalnes

UNKNOWN

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ole-Bjørn Tysnes

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Nordland Hospital Bodø

Bodø, Nordland, Norway

Site Status: RECRUITING

Sørlandet Hospital Trust

Kristiansand, Vest Agder, Norway

Site Status: RECRUITING

Haukeland University Hospital

Bergen, , Norway

Site Status: RECRUITING

Akershus University Hospital

Lørenskog, , Norway

Site Status: RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Østfold Hospital Kalnes

Sarpsborg, , Norway

Site Status: NOT_YET_RECRUITING

Stavanger University Hospital

Stavanger, , Norway

Site Status: RECRUITING

Universitetssykehuset Nord-Norge

Tromsø, , Norway

Site Status: RECRUITING

St. Olavs Hospital

Trondheim, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Ole-Bjørn Tysnes

Role: CONTACT

ole-bjorn.tysnes@helse-bergen.no

+ 47 55975063

Tale Litlere Bjerknes

Role: CONTACT

tale.litlere.bjerknes@helse-bergen.no

+47 55975045

Facility Contacts

Ane Sjulstad, MD

Role: primary

Ane.Skaare.Sjulstad@nordlandssykehuset.no

75571000 ext. +47

Hildegunn Øverlie, MD

Role: primary

hildegunn.overlie@sshf.no

38073000 ext. + 47

Ole-Bjørn Tysnes

Role: primary

ole-bjorn.tysnes@helse-bergen.no

+4755975063

Ola Nakken

Role: primary

Angelina Maniaol

Role: primary

Sophie Cranner Seip, MD

Role: primary

Sophie.Cranner.Seip@so-hf.no

69 86 00 00 ext. +47

Katrin Ruth Schlüter

Role: primary

Agnethe Eltoft, MD

Role: primary

agnethe.eltoft@unn.no

+4777627075

Monica Vold, MD

Role: backup

monica.linnea.vold@unn.no

Eivind Brønstad, MD PhD

Role: primary

Other Identifiers

492102

Identifier Type: -

Identifier Source: org_study_id