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 hospitalThe 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:
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