The Evolution of Invasive Home Mechanical Ventilation in Denmark
Observational study on home breathing support in Denmark
Plain English Summary
Invasive Home Ventilation in Denmark is a Not Applicable clinical trial sponsored by Rigshospitalet, Denmark studying Neuromuscular Diseases (NMD), ALS (Amyotrophic Lateral Sclerosis), Spinal Cord Injuries (SCI), Duchenne Muscular Dystrophy (DMD), SMA - Spinal Muscular Atrophy, MSA - Multiple System Atrophy, Tracheostomized Patients, Tracheostomy. This study looks at how many people in Denmark have used breathing machines at home over the last 10 years. It's for patients with serious muscle weakness or breathing problems who need a breathing tube at home. Participation involves reviewing existing medical records; no new treatments are given. There are no direct alternatives as this is an observational study, but it informs future care. The trial aims to enroll 450 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have or had a certified caregiver to help with breathing support at home between 2016 and 2025. You cannot join if you do not have a breathing tube (tracheostomy). You also cannot join if you had a breathing tube but were breathing on your own throughout the study period. You must have been discharged home or to a care facility during the study period. This trial is studying Neuromuscular Diseases (NMD), ALS (Amyotrophic Lateral Sclerosis), Spinal Cord Injuries (SCI), Duchenne Muscular Dystrophy (DMD), SMA - Spinal Muscular Atrophy, MSA - Multiple System Atrophy, Tracheostomized Patients, Tracheostomy, so participants generally need a confirmed diagnosis.
What They're Measuring
The main outcome measures how many people each year needed breathing machines at home, showing trends in who receives this support. The specific primary outcome measures are: Incidence of patients with invasive home mechanical ventilation (Each year during the periode from 01.01.2016 to 12.31.2025). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This study is important because it will help understand how home breathing support is used for people with serious conditions, filling a gap in knowledge for better future care. This research targets Neuromuscular Diseases (NMD), ALS (Amyotrophic Lateral Sclerosis), Spinal Cord Injuries (SCI), Duchenne Muscular Dystrophy (DMD), SMA - Spinal Muscular Atrophy, MSA - Multiple System Atrophy, Tracheostomized Patients, Tracheostomy, where improved treatment options are needed.
Investor Insight
This observational study provides valuable data on the use of home mechanical ventilation, which could inform market needs and competitive strategies for respiratory support technologies and services.
Is This Trial Right for Me?
Ask your doctor if your condition might be included in this type of study. This study uses past medical information, so you won't need to do anything new. The study team will look at your health records from 2016 to 2025. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 450 participants
Primary Outcomes
- Incidence of patients with invasive home mechanical ventilation (Each year during the periode from 01.01.2016 to 12.31.2025)
Secondary Outcomes
- 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 (Each year during the periode from 01.01.2016 to 12.31.2025)
- One-year mortality (Periode from 01.01.2016 to 12.31.2025)
Full Eligibility Criteria
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
Trial Locations
- Respiratory Center East, Copenhagen, Denmark
Frequently Asked Questions
What is clinical trial NCT07467187?
NCT07467187 is a Not Applicable OBSERVATIONAL study titled "Invasive Home Ventilation in Denmark." It is currently not yet recruiting and is sponsored by Rigshospitalet, Denmark. The trial targets enrollment of 450 participants.
What conditions does NCT07467187 study?
This trial investigates treatments for Neuromuscular Diseases (NMD), ALS (Amyotrophic Lateral Sclerosis), Spinal Cord Injuries (SCI), Duchenne Muscular Dystrophy (DMD), SMA - Spinal Muscular Atrophy, MSA - Multiple System Atrophy, Tracheostomized Patients, Tracheostomy. The primary condition under study is Neuromuscular Diseases (NMD).
What does Not Applicable mean for NCT07467187?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07467187?
This trial is currently "Not Yet Recruiting." It started on 2026-04-01. The estimated completion date is 2028-09-01.
Who is sponsoring NCT07467187?
NCT07467187 is sponsored by Rigshospitalet, Denmark. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07467187?
The trial aims to enroll 450 participants. The trial has not yet started recruiting.
How is NCT07467187 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07467187?
The primary outcome measures are: Incidence of patients with invasive home mechanical ventilation (Each year during the periode from 01.01.2016 to 12.31.2025). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07467187 being conducted?
This trial is being conducted at 1 site, including Copenhagen (Denmark).
Where can I find official information about NCT07467187?
The official record for NCT07467187 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07467187. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07467187 testing in simple terms?
This study looks at how many people in Denmark have used breathing machines at home over the last 10 years. It's for patients with serious muscle weakness or breathing problems who need a breathing tube at home.
Why is this trial significant?
This study is important because it will help understand how home breathing support is used for people with serious conditions, filling a gap in knowledge for better future care.
What are the potential risks of participating in NCT07467187?
As this is an observational study using existing data, there are no direct risks to patients. The main 'risk' is that your past medical information will be reviewed. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07467187?
Ask your doctor if your condition might be included in this type of study. This study uses past medical information, so you won't need to do anything new. The study team will look at your health records from 2016 to 2025. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07467187 signal from an investment perspective?
This observational study provides valuable data on the use of home mechanical ventilation, which could inform market needs and competitive strategies for respiratory support technologies and services. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves reviewing existing medical records; no new treatments are given. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.