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)

Study Purpose:

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 Status:

Not yet recruiting

Disease:

Amyotrophic Lateral Sclerosis

Study Type:

Interventional

Type of Intervention:

N/A

Intervention Name:

Outpatient, Hospitalization

Placebo:

Yes

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

N/A

Clinicaltrials.gov ID:

NCT05829330

Neals Affiliated?

No

Coordinating Center Contact Information

Study Sponsor:

Anne Kathrine Staehr-Rye

Estimated Enrollment:

46

Estimated Study Start Date:

04 / 01 / 2023

Estimated Study Completion Date:

11 / 01 / 2024

Posting Last Modified Date:

04 / 25 / 2023

Date Study Added to neals.org:

04 / 25 / 2023

Minimum Age:

18 Years

Maximum Age:

N/A

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