Invasive Home Ventilation in Denmark (HOMEVENT DK)

The Evolution of Invasive Home Mechanical Ventilation in Denmark

The aim of this study is to describe national trends over the past 10 years in patients receiving invasive home mechanical ventilation (HMV) in Denmark. This includes indications for invasive HMV, diagnostic groups, and one-year mortality.

Study Overview

• Status: Recruiting
• Conditions: Tracheostomy; ALS (Amyotrophic Lateral Sclerosis); Duchenne Muscular Dystrophy (DMD); MSA - Multiple System Atrophy; Spinal Cord Injuries (SCI); SMA - Spinal Muscular Atrophy; Tracheostomized Patients; Neuromuscular Diseases (NMD)

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Janne B Stokholm, M.D.; Phone Number: +45 38632376; Email: janne.boegh.stokholm.01@regionh.dk
• Study Contact Backup: Name: Anne-Katrine Staehr-Rye; Phone Number: +45 24455276; Email: anne.kathrine.staehr.rye@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2600
    • Recruiting
    • Respiratory Center East
    • Contact: Anne-Katrine Staehr-Rye; Phone Number: +45 24455276; Email: anne.kathrine.staehr.rye@regionh.dk
    • Contact: Janne B Stokholm; Phone Number: +45 38632376; Email: janne.boegh.stokholm.01@regionh.dk
    • Principal Investigator: Janne B Stokholm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in Denmark with a respiratory certified personale care assistent who are fully or partially dependent on invasive ventilation during the period 2016-2025.

Description

Inclusion Criteria:

• Patients are included if they have or have had a respiratory certified personale care assistent during the period 2016-2025.

Exclusion Criteria:

• Not tracheostomized
• Tracheostomized but on spontaneous breathing throughout 1 January 2016 - 31 December 2025
• Not discharged to home, assisted living, nursing home, or rehabilitation during 1 January 2016 - 31 December 2025

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Invasive mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of patients with invasive home mechanical ventilation	Incidence of patients with invasive home mechanical ventilation per year per 100,000 population	Each year during the periode from 01.01.2016 to 12.31.2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of patients on home mechanical ventilation pr. year		Each year during the periode from 01.01.2016 to 12.31.2025
Number of new patients on invasive home mechanical ventilation per year	The absolute number of patients starting on invasive home mechanical ventilation each year.	Each year during the periode from 01.01.2016 to 12.31.2025
One-year mortality	1-year mortality after initiation of invasive home mechanical ventilation	Periode from 01.01.2016 to 12.31.2025

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Odense University Hospital; Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Wounds and Injuries; Genetic Diseases, Inborn; Metabolic Diseases; Neurodegenerative Diseases; Movement Disorders; Trauma, Nervous System; Genetic Diseases, X-Linked; Muscular Disorders, Atrophic; Basal Ganglia Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Primary Dysautonomias; Autonomic Nervous System Diseases; Motor Neuron Disease; Hypotension; Muscular Dystrophies; Multiple System Atrophy; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Amyotrophic Lateral Sclerosis; Muscular Dystrophy, Duchenne; Spinal Cord Injuries; Shy-Drager Syndrome; Muscular Atrophy, Spinal; Neuromuscular Diseases
• Other Study ID Numbers: p-2025-20512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No