Ambulatory Versus Inpatient Initiation of Home Mechanical Ventilation

March 10, 2026 updated by: Anne Kathrine Staehr-Rye

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • 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 Locations

  • Denmark
      • Glostrup Municipality, Denmark, 2600
        • Department of Anaesthesia, Pain and REspiratory Support

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Outpatient
Outpatient initiation of non-invasive mechanical ventilation
Other: Outpatient
Outpatient Initiation of noninvasive mechanical ventilation
Placebo Comparator: Hospitalization
Initiation of non-invasive mechanical ventilation during hospitalization
Other: Hospitalization
Initiation of non-invasive mechanical ventilation during hospitalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The 83th to the 90th day after initiation of non-invasive mechanical ventilation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Measured at the 3 months follow-up visit
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)
Measured at the 3 months follow-up visit

Collaborators and Investigators

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

Sponsor

Anne Kathrine Staehr-Rye

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)

September 20, 2023

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-23005093

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

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.

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