NCT07428694

Brief Summary

Study of the applicability of machine learning tools in detecting inspiratory leakage in longterm non-invasive ventilation. The study was conducted in two stages. Firstly the ML model was trained on both bench model created scenarios and then ten patients. And secondly the success of the model was assessed in a proof of concept pilot study of ten patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
3mo left

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Oct 2025Oct 2026

Study Start

First participant enrolled

October 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 17, 2026

Last Update Submit

February 17, 2026

Conditions

Chronic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Correct interpretation of inspiratory leak by machine learning tool

    Measured in comparison with god standard method of polygraphy

    one year

Eligibility Criteria

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

Patients undergoing treatment with Lumis 100/150 for type 2 chronic resiratory failure

You may qualify if:

  • elective hospitalisation for control of non-invasive ventilation
  • use of ResMedLumis 100/150 ventilator
  • treatment for \>3 months

You may not qualify if:

  • current exacerbation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 17, 2026

First Posted

February 24, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations

NO(1)