NCT07819890

Brief 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 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. .

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Oct 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Oct 2026Jan 2027

First Submitted

Initial submission to the registry

September 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 9, 2026

Last Update Submit

September 9, 2026

Conditions

Amyotrophic Lateral SclerosisHome Mechanical Ventilation

Outcome Measures

Primary Outcomes (2)

  • Positive predictive value of HMV codes for invasive HMV

    2012-2025

  • Positive predictive value of HMV codes for non-invasive HMV

    2012-2025

Study Arms (2)

Invasive home mechanical ventilation

Noninvasive home mechanical ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with amyotrophic lateral sclerosis

You may qualify if:

  • 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)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Anne Kathrine Staehr-rye, MD, Ph.D

CONTACT

004528665645Anne.kathrine.staehr.rye@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 15, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

September 15, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share