NCT05829330Completed
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)
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 15 Mar 2023
- Start date
- 20 Sept 2023
- Primary completion date
- 1 May 2026
- Lead sponsor
- Anne Kathrine Staehr-Rye
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT05829330
What you commit to
- Study type: Interventional
- Participants enrolled: 46
- From 20 Sept 2023 to the primary completion date, 1 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- No informed consent
- Does not understand Danish or English
- Indication for invasive mechanical ventilation
- No morning baseline PCO2
- Hospitalization
Who the study is looking for
- Age \> 18 years
- Diagnosed with amyotrophic lateral sclerosis
- Indication for start of non-invasive mechanical ventilation
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Anaesthesia, Pain and REspiratory Support Coordinator of this site? Confirm its status | Glostrup Municipality | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.