Amyotrophic Lateral SclerosisNCT07819890
Development in Home Mechanical Ventilation for Patient With Amyotrophic Lateral Sclerosis.
An observational study of Amyotrophic Lateral Sclerosis and Home Mechanical Ventilation, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
The aims of the study are to calculate the positive predictive value (PPV) of the codes for home mechanical noninvasive and invasive ventilation in patients with Amyotrophic lateral sclerosis in Denmark, and to describe the initial clinical characteristics of patients with ALS and invasive and noninvasive HMV between… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Home Mechanical Ventilation
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Jan 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with amyotrophic lateral sclerosis
Who may be able to join
- Patients with at least two hospital contacts from 2012 and 2026 with an ALS diagnosis
- Patients with one hospital contacts from 2012 and 2026 with a diagnosis or procedure codes related to mechanical ventilation
- Patients with one hospital contacts from 2012 and 2026 with a process marker related to mechanical ventilation (SKS, sundhedsklassifikationssystem)
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aims of the study are to calculate the positive predictive value (PPV) of the codes for home mechanical noninvasive and invasive ventilation in patients with Amyotrophic lateral sclerosis in Denmark, and to describe the initial clinical characteristics of patients with ALS and invasive and noninvasive HMV between 2012 and 2026. Moreover, the study will describe the national development of home mechanical ventilation for patient with ALS, including calculating the incidence, prevalence and mortality of the the patients with invasive HMV. .
- Medical subject headings
- Amyotrophic Lateral Sclerosis
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 home mechanical ventilation | Not described | |
| Noninvasive home mechanical ventilation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value of HMV codes for invasive HMV
Measured: 2012-2025
Positive predictive value of HMV codes for non-invasive HMV
Measured: 2012-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Kathrine Staehr-Rye, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819890
- Sponsor's protocol ID
- R-26010333
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development in Home Mechanical Ventilation for Patient With Amyotrophic Lateral Sclerosis.
- ClinicalTrials.gov ID
- NCT07819890
- Acronym / sponsor ID
- R-26010333
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 15 Sep 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 aims of the study are to calculate the positive predictive value (PPV) of the codes for home mechanical noninvasive and invasive ventilation in patients with Amyotrophic lateral sclerosis in Denmark, and to describe the initial clinical characteristics of patients with ALS and invasive and noninvasive HMV between 2012 and 2026. Moreover, the study will describe the national development of home mechanical ventilation for patient with ALS, including calculating the incidence, prevalence and mortality of the the patients with invasive HMV. .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invasive home mechanical ventilation | – | – |
| Noninvasive home mechanical ventilation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with amyotrophic lateral sclerosis
Key inclusion criteria (3 listed)
- Patients with at least two hospital contacts from 2012 and 2026 with an ALS diagnosis
- Patients with one hospital contacts from 2012 and 2026 with a diagnosis or procedure codes related to mechanical ventilation
- Patients with one hospital contacts from 2012 and 2026 with a process marker related to mechanical ventilation (SKS, sundhedsklassifikationssystem)
Key exclusion criteria (1 listed)
- None
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
Positive predictive value of HMV codes for invasive HMV
Time frame: 2012-2025
Positive predictive value of HMV codes for non-invasive HMV
Time frame: 2012-2025
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 15 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis and Home Mechanical Ventilation, run by Copenhagen University Hospital, Rigshospitalet.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Anne Kathrine Staehr-rye, MD, Ph.D (004528665645, Anne.kathrine.staehr.rye@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive value of HMV codes for invasive HMV (time frame: 2012-2025). The study lists 2 primary outcomes in all. 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 15 Sep 2026.