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NCT Number: NCT06286917

Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Ventilation Therapy ALS Chronic Respiratory Failure

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital

Tampere, 33520, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIV initiation in patients with ALS

Other

NIV initiation according to standard care

Primary outcomes

  1. NIV usage hours according to different initiation locations in patients with ALS

    Time frame: 5 years

    NIV daily usage hours in the 3-month control after initiation (determined over the preceding month)

  2. Compliance with NIV according to NIV initiation setting in patients with ALS

    Time frame: 5 years

    Association between the initiation method and the patients' compliance with the goal of using NIV more than 4 hours per day.

  3. Decrease in blood carbon dioxide levels in patients with ALS depending on the place of NIV initiation.

    Time frame: 5 years

    The effectiveness of the treatment on the reduction of blood carbon dioxide pressure

Other outcomes

  1. Costs of initiation of NIV in outpatient setting compared with inpatient setting in patients with ALS

    Time frame: 5 years

    How much does the initiation of NIV cost in outpatient setting compared with initiation in a pulmonary ward including all the contacts with a nurse and a doctor during the following year after the initiation.

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Registry information

Acronym: InNIVALS

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Feb 29, 2024
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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