NCT05829330

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: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Anne Kathrine Staehr-Rye · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
OTHER	Outpatient	Outpatient Initiation of noninvasive mechanical ventilation
OTHER	Hospitalization	Initiation of non-invasive mechanical ventilation during hospitalization

Timeline

• Start date: 2023-09-20
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2023-04-25
• Last updated: 2026-03-12

Locations

1 site across 1 country: Denmark