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Recruiting NCT06286917

Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency

No phase Interventional Ventilation Therapy ALS Chronic Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NIV initiation in patients with ALS.
Who it may be relevant to
Registry conditions: Ventilation Therapy, ALS, Chronic Respiratory Failure. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This research will study whether noninvasive ventilation (NIV) used to treat chronic respiratory insufficiency in patients with amyotrophic lateral sclerosis (ALS) can be initiated as successfully in the outpatient setting as in the conventional inpatient setting, and what the costs of these alternative initiation methods are.

Interventions

  • Other NIV initiation in patients with ALS
    NIV initiation according to standard care

Primary outcome measures

  • NIV usage hours according to different initiation locations in patients with ALS [Time frame: 5 years]
  • Compliance with NIV according to NIV initiation setting in patients with ALS [Time frame: 5 years]
  • Decrease in blood carbon dioxide levels in patients with ALS depending on the place of NIV initiation. [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • ALS diagnosed by a neurology and
  • chronic respiratory insufficiency or significant respiratory muscle weakness caused by ALS

Exclusion criteria

  • impaired cognition to give informed consent to participation
  • contraindication to NIV therapy
  • another severe disease with a prognosis of less than one year
  • ventilation via an artificial airway, tracheostomy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

Finland · 1 center
  • Tampere University Hospital — Tampere

Identifiers

NCT: NCT06286917 · R24001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗