Neuromuscular Diseases (NMD)HOMEVENT DKNCT07467187
Invasive Home Ventilation in Denmark
An observational study of Neuromuscular Diseases (NMD) and ALS (Amyotrophic Lateral Sclerosis), run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuromuscular Diseases (NMD), ALS (Amyotrophic Lateral Sclerosis), Spinal Cord Injuries (SCI)
- How many people
- 450 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Apr 2026to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients are included if they have or have had a respiratory certified personale care assistent during the period 2016-2025.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Respiratory Center East
Copenhagen, 2600
Janne B Stokholm, +45 38632376, janne.boegh.stokholm.01@regionh.dk
Anne-Katrine Staehr-Rye, +45 24455276, anne.kathrine.staehr.rye@regionh.dk
About this study
Official title: 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.
- Conditions
- Neuromuscular Diseases (NMD), ALS (Amyotrophic Lateral Sclerosis), Spinal Cord Injuries (SCI), Duchenne Muscular Dystrophy (DMD), SMA - Spinal Muscular Atrophy, MSA - Multiple System Atrophy
- Medical subject headings
- Neuromuscular Diseases, Amyotrophic Lateral Sclerosis, Spinal Cord Injuries, Muscular Dystrophy, Duchenne, Muscular Atrophy, Spinal, Shy-Drager Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Invasive mechanical ventilation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patients with invasive home mechanical ventilation
Incidence of patients with invasive home mechanical ventilation per year per 100,000 population
Measured: Each year during the periode from 01.01.2016 to 12.31.2025
Secondary outcomes (3)
Prevalence of patients on home mechanical ventilation pr. year
Measured: 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.
Measured: 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
Measured: Periode from 01.01.2016 to 12.31.2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start13 Apr 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular Diseases (NMD)Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital
- Responsible party
- Principal investigator, Janne B Stokholm, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467187
- Sponsor's protocol ID
- p-2025-20512
- Acronym
- HOMEVENT DK
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evolution of Invasive Home Mechanical Ventilation in Denmark
- ClinicalTrials.gov ID
- NCT07467187
- Acronym / sponsor ID
- HOMEVENT DK / p-2025-20512
- Conditions
- Neuromuscular Diseases (NMD), ALS (Amyotrophic Lateral Sclerosis), Spinal Cord Injuries (SCI), Duchenne Muscular Dystrophy (DMD), SMA - Spinal Muscular Atrophy, MSA - Multiple System Atrophy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invasive mechanical ventilation | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients are included if they have or have had a respiratory certified personale care assistent during the period 2016-2025.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of patients with invasive home mechanical ventilation
Time frame: Each year during the periode from 01.01.2016 to 12.31.2025
Incidence of patients with invasive home mechanical ventilation per year per 100,000 population
3 secondary outcomes
Prevalence of patients on home mechanical ventilation pr. year
Time frame: Each year during the periode from 01.01.2016 to 12.31.2025
Number of new patients on invasive home mechanical ventilation per year
Time frame: Each year during the periode from 01.01.2016 to 12.31.2025
One-year mortality
Time frame: Periode from 01.01.2016 to 12.31.2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases (NMD) and ALS (Amyotrophic Lateral Sclerosis), run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janne B Stokholm, M.D. (+45 38632376, janne.boegh.stokholm.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of patients with invasive home mechanical ventilation (time frame: Each year during the periode from 01.01.2016 to 12.31.2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.