Chronic Obstructive Pulmonary DiseaseTeleInterVENTNCT05287555
Efficacy of Telemetry-assisted Care in Home Home Vented COPD
A study testing Telemonitoring Care in people with Chronic Obstructive Pulmonary Disease, run by Georg Nilius, Prof DR med at 1 site in Germany.
Trial summary
This study in patients suffering of Chronic Obstructive Pulmonary disease (COPD) aims to investigate whether telemonitoring of their non invasive ventilation (NIV) device together with targeted, tailored intervention in case of increasing symptoms or ventilation abnormalities improves the therapy adherence and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Telemonitoring Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- 25 Apr 2022to 24 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NIV-naive / Continuation after 3 Months Interruption
- Indication for initiation of NIV according to S2k guideline of the German Society of Pneumology
- Presence of the signed informed consent
Who cannot join
- Absence of signed written informed consent for data protection and study participation.
- contraindication to PAP therapy
- Participation in another study that influences the setting of NIV therapy through specifications regarding device settings or titration
Trial locations and contacts
1 site in 1 country.
Germany1 site
Evang. Kliniken Essen-Mitte gGmbH
Essen, North Rhine-Westphalia, 45276
About this study
Official title: Randomisiert-kontrollierte Klinische Studie an häuslich Beatmeten COPD-Patienten Zur Überprüfung Der Wirksamkeit Einer Telemetrisch unterstützten Fernbetreuung Durch Das Beatmungszentrum im Vergleich Zur stationären, halbjährlichen Beatmungskontrolle gemäß Leitlinie [Randomized-controlled Clinical Trial in Home Ventilated COPD Patients to Test the Efficacy of Telemetry-assisted Care Compared to Biannual Inpatient Ventilation Control Visits According to the Guideline]
This study in patients suffering of Chronic Obstructive Pulmonary disease (COPD) aims to investigate whether telemonitoring of their non invasive ventilation (NIV) device together with targeted, tailored intervention in case of increasing symptoms or ventilation abnormalities improves the therapy adherence and effectiveness and can reduce the need for hospitalizations.
Read the detailed description
54 NIV naive COPD patients will be randomized to either telemonitoring care with a data-based intervention scheme or standard care according to the guideline of the German Society of Pneumology.
Primary objective:
Adherence to ventilation in the intervention group versus control group.
Secondary objective:
Comparisons between the control and intervention groups, over time and against each other, in terms of:
- Health-related quality of life assessed by SGRQ
- Symptomatology based on blood gas analyses, CAT score, mMRC score and S3-NIV score
- Therapy quality according to therapy parameters from device data
- Number of hospitalizations and physician visits
- Evaluation of the impact of feedback and interventions on therapy adherence, symptomatology and therapy data.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Telemonitoring Care, Standard Care
- Keywords
- COPD, NIV, Telemonitoring
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring CareOther
NIV, Supplies as needed, especially masks, tubes, humidifiers, SpO2 sensor and modems.
Standard CareOther
NIV, Supplies as needed, especially masks, tubes, humidifiers, and modems
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Home non-invasive mask ventilation with prisma VENT device. Modem for the daily transmission of specific therapy parameters.
Standard care according to clinical standard (technical support by the provider and three hospital follow-up appointments after 2, 6 and after 12 months) with assessment of health status and NIV therapy settings.
Study specific: During visits, recording of HRQOL by SGRQ and S3NIV questionnaires, hospitalizaion and physician visits.
Therapy data from NIV device. Receives: Other: Standard Care |
| Telemonitoring | Experimental | Home non-invasive mask ventilation with prisma VENT device. Modem for the daily transmission of specific therapy parameters. An electronic feedback system provides patients with feedback and recommendations on their therapy based on the data submitted.
The study center regularly reviews and reacts to all therapy data and other information according to the remote care scheme of intervention.
Telemonitoring care patients also receive an SpO2 sensor for monitoring of oxygen saturation.
Ambulantory implementation of three blood gas analyses to check the health status after 2, 6 and 12 months. There are no regular routine inpatient stays.
Study specific: During visits, recording of HRQOL by SGRQ and S3NIV questionnaires, hospitalizaion and physician visits. Receives: Other: Telemonitoring Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence [hours/day]
Usage of Ventilator in hours per day
Measured: 12 Months
Secondary outcomes (1)
QOL [unit]
Health related Quality of Life by SGRQ-Score [higher units represent worse outcome]
Measured: Survey at 3 dates: 2, 6 und 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start25 Apr 2022
- Primary completion15 Apr 2025
- Study completion24 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, double-arm, controlled-randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georg Nilius, Prof DR med
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Heinen und Löwenstein GmbH & Co. KG
- Responsible party
- Sponsor-investigator, Georg Nilius, Prof DR med, Institut für Pneumologie Hagen Ambrock eV
- Investigators
- Gearg Nilius, MD, Principal investigator, KEM | Evang. Kliniken Essen-Mitte gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287555
- Sponsor's protocol ID
- TIV2022
- Acronym
- TeleInterVENT
- Status last verified
- Nov 2025
- First submitted
- 24 Feb 2022
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomisiert-kontrollierte Klinische Studie an häuslich Beatmeten COPD-Patienten Zur Überprüfung Der Wirksamkeit Einer Telemetrisch unterstützten Fernbetreuung Durch Das Beatmungszentrum im Vergleich Zur stationären, halbjährlichen Beatmungskontrolle gemäß Leitlinie [Randomized-controlled Clinical Trial in Home Ventilated COPD Patients to Test the Efficacy of Telemetry-assisted Care Compared to Biannual Inpatient Ventilation Control Visits According to the Guideline]
- ClinicalTrials.gov ID
- NCT05287555
- Acronym / sponsor ID
- TeleInterVENT / TIV2022
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, NIV, Telemonitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Georg Nilius, Prof DR medIndustry (pharma, biotech, devices)
- Collaborators
- Heinen und Löwenstein GmbH & Co. KG
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 18 Mar 2022 (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.
This study in patients suffering of Chronic Obstructive Pulmonary disease (COPD) aims to investigate whether telemonitoring of their non invasive ventilation (NIV) device together with targeted, tailored intervention in case of increasing symptoms or ventilation abnormalities improves the therapy adherence and effectiveness and can reduce the need for hospitalizations.
Detailed description
54 NIV naive COPD patients will be randomized to either telemonitoring care with a data-based intervention scheme or standard care according to the guideline of the German Society of Pneumology.
Primary objective:
Adherence to ventilation in the intervention group versus control group.
Secondary objective:
Comparisons between the control and intervention groups, over time and against each other, in terms of:
- Health-related quality of life assessed by SGRQ
- Symptomatology based on blood gas analyses, CAT score, mMRC score and S3-NIV score
- Therapy quality according to therapy parameters from device data
- Number of hospitalizations and physician visits
- Evaluation of the impact of feedback and interventions on therapy adherence, symptomatology and therapy data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, double-arm, controlled-randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Standard CareHome non-invasive mask ventilation with prisma VENT device. Modem for the daily transmission of specific therapy parameters. Standard care according to clinical standard (technical support by the provider and three hospital follow-up appointments after 2, 6 and after 12 months) with assessment of health status and NIV therapy settings. Study specific: During visits, recording of HRQOL by SGRQ and S3NIV questionnaires, hospitalizaion and physician visits. Therapy data from NIV device. |
| Telemonitoring | Experimental | Other: Telemonitoring CareHome non-invasive mask ventilation with prisma VENT device. Modem for the daily transmission of specific therapy parameters. An electronic feedback system provides patients with feedback and recommendations on their therapy based on the data submitted. The study center regularly reviews and reacts to all therapy data and other information according to the remote care scheme of intervention. Telemonitoring care patients also receive an SpO2 sensor for monitoring of oxygen saturation. Ambulantory implementation of three blood gas analyses to check the health status after 2, 6 and 12 months. There are no regular routine inpatient stays. Study specific: During visits, recording of HRQOL by SGRQ and S3NIV questionnaires, hospitalizaion and physician visits. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- NIV-naive / Continuation after 3 Months Interruption
- Indication for initiation of NIV according to S2k guideline of the German Society of Pneumology
- Presence of the signed informed consent
Key exclusion criteria (3 listed)
- Absence of signed written informed consent for data protection and study participation.
- contraindication to PAP therapy
- Participation in another study that influences the setting of NIV therapy through specifications regarding device settings or titration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemonitoring CareNIV, Supplies as needed, especially masks, tubes, humidifiers, SpO2 sensor and modems. | Other | Telemonitoring |
| Standard CareNIV, Supplies as needed, especially masks, tubes, humidifiers, and modems | Other | Control |
Primary outcome
Adherence [hours/day]
Time frame: 12 Months
Usage of Ventilator in hours per day
1 secondary outcome
QOL [unit]
Time frame: Survey at 3 dates: 2, 6 und 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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. This study is not recruiting at the moment.
Gearg Nilius, MD principal investigator
KEM | Evang. Kliniken Essen-Mitte gGmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring Care in people with Chronic Obstructive Pulmonary Disease, run by Georg Nilius, Prof DR med at 1 site in Germany.
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 3 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: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence [hours/day] (time frame: 12 Months). 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 2 Dec 2025.