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Home Tele-Monitoring of Non-Invasive Ventilation in COPD Patients in France

Home Tele-Monitoring of Non-Invasive Ventilation in Chronic Obstructive Pulmonary Disease in France

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05815420
Acronym
HOV-C
Enrollment
40
Registered
2023-04-18
Start date
2023-09-01
Completion date
2025-12-30
Last updated
2023-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Non invasive ventilation, Telemonitoring

Brief summary

Tele-monitoring emerged and unfolded differently among various healthcare organisations and countries. Evidence regarding its impact on the management of COPD patients is still insufficient to draw firm conclusions. Assumption has been made that remote monitoring of home NIV treatment could help to identify novel predictors of the early detection of NIV failure and deteriorations in patients with COPD. The incidence in routine clinical care of unplanned all-cause and COPD-caused hospitalisations in patients treated with NIV therapy who are continuously monitored by telemetric data in France needs evaluation. In addition, predictors of unplanned all-cause and COPD-caused hospitalisations as well as of compliance and persistence to NIV therapy should be assessed in this patient population with special respect to continuous tele-monitoring. The study will determine in France the incidence in routine clinical care of unplanned all-cause and COPD-caused hospitalisations in patients treated with NIV therapy who are continuously monitored by telemetric data. Clinical and telemetric predictors of unplanned all-cause and COPD-caused hospitalisations and of NIV therapy compliance and persistence will be assessed in those patients

Interventions

DEVICENon invasive ventilation

Treatment by non invasive ventilation

Sponsors

Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Age ≥18 years * COPD eligible for NIV treatment * Prescription of an adequate ResMed NIV device with tele-monitoring option as part of routine clinical care * Acceptance of tele-monitoring and corresponding data handling * Naive to long-term NIV treatment with initiation of NIV either ≤7 days before or after enrolment into study * Able to fully understand information on data protection and provide written informed consent for use of corresponding medical and telemetric data.

Exclusion criteria

* Invasive ventilation therapy * Another life-threatening disease with estimated survival \< 12 months (other than COPD, e.g. cancer) * Further

Design outcomes

Primary

MeasureTime frameDescription
Incidence of unplanned all-cause hospitalisations in routine clinical care in patients treated with NIV therapy who are continuously monitored by telemetric data1 yearRate of unplanned all-cause hospitalisations in the study population normalised to one year of follow up

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026