NCT05829330

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

September 20, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

March 15, 2023

Last Update Submit

March 10, 2026

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Use of non-invasive mechanical ventilation

    Use of non-invasive mechanical ventilation in minutes per day

    The 83th to the 90th day after initiation of non-invasive mechanical ventilation

Secondary Outcomes (2)

  • Patient satisfaction with the treatment

    Measured at the 3 months follow-up visit

  • Patient satisfaction with the proces in relation to the start of the treatment

    Measured at the 3 months follow-up visit

Study Arms (2)

Outpatient

ACTIVE COMPARATOR

Outpatient initiation of non-invasive mechanical ventilation

Other: Outpatient

Hospitalization

PLACEBO COMPARATOR

Initiation of non-invasive mechanical ventilation during hospitalization

Other: Hospitalization

Interventions

OutpatientOTHER

Outpatient Initiation of noninvasive mechanical ventilation

Outpatient
HospitalizationOTHER

Initiation of non-invasive mechanical ventilation during hospitalization

Hospitalization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Diagnosed with amyotrophic lateral sclerosis
  • Indication for start of non-invasive mechanical ventilation

You may not qualify if:

  • No informed consent
  • Does not understand Danish or English
  • Indication for invasive mechanical ventilation
  • No morning baseline PCO2
  • Hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesia, Pain and REspiratory Support

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Hospitalization

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 15, 2023

First Posted

April 25, 2023

Study Start

September 20, 2023

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)