Ambulatory Versus Inpatient Initiation of Home Mechanical Ventilation

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)

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05829330

Enrollment

Registered

2023-04-25

Start date

2023-09-20

Completion date

2026-05-01

Last updated

2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Brief summary

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.

Interventions

OTHEROutpatient

Outpatient Initiation of noninvasive mechanical ventilation

OTHERHospitalization

Initiation of non-invasive mechanical ventilation during hospitalization

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Use of non-invasive mechanical ventilation	The 83th to the 90th day after initiation of non-invasive mechanical ventilation	Use of non-invasive mechanical ventilation in minutes per day

Secondary

Measure	Time frame	Description
Patient satisfaction with the treatment	Measured at the 3 months follow-up visit	Patient satisfaction with the non-invasive mechanical ventilation (verbal-rating-score 1-5)
Patient satisfaction with the proces in relation to the start of the treatment	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)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026