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OpenTrials
Completed

NCT Number: NCT05829330

Ambulatory Versus Inpatient Initiation of Home Mechanical Ventilation

The purpose of this investigation is to see if outpatient initiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up in patients with amyotrophic lateral sclerosis is non-inferior to initiation during admission to the hospital

The primary hypothesis is that outpatient intiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up is non-inferior to initiation during hospitalization in patients with amyotrophic lateral sclerosis.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesia, Pain and REspiratory Support

Glostrup Municipality, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years
  • Diagnosed with amyotrophic lateral sclerosis
  • Indication for start of non-invasive mechanical ventilation

Exclusion criteria

  • No informed consent
  • Does not understand Danish or English
  • Indication for invasive mechanical ventilation
  • No morning baseline PCO2
  • Hospitalization

Treatment and study plan

Outpatient

Other

Outpatient Initiation of noninvasive mechanical ventilation

Hospitalization

Other

Initiation of non-invasive mechanical ventilation during hospitalization

Primary outcomes

  1. Use of non-invasive mechanical ventilation

    Time frame: The 83th to the 90th day after initiation of non-invasive mechanical ventilation

    Use of non-invasive mechanical ventilation in minutes per day

Secondary outcomes

  1. Patient satisfaction with the treatment

    Time frame: Measured at the 3 months follow-up visit

    Patient satisfaction with the non-invasive mechanical ventilation (verbal-rating-score 1-5)

  2. Patient satisfaction with the proces in relation to the start of the treatment

    Time frame: Measured at the 3 months follow-up visit

    Patient satisfaction with the proces in relation to the start of non-invasive mechanical ventilation (verbal-rating-score 1-5)

Sponsors and collaborators

Lead sponsor

Anne Kathrine Staehr-Rye

Other

Registry information

Official study title

Ambulatory Versus Inpatient Initiation of Home Non-invasive Mechanical Ventilation in Patient With Amyotrophic Lateral Sclerosis: a Prospective, Noninferiority Randomized Controlled Trial (The NIB-study)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2023
Registry last updated
Jun 23, 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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