Chronic Respiratory FailureNOCTIVENTNCT05756387
Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach
An observational study of Chronic Respiratory Failure and Non-invasive Ventilation, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The aim of the data collection is to create an advanced reliable method to remotely monitor patient on chronic home non-invasive ventilation (NIV), both regarding ventilatory efficacy and patient comfort, both in the hospital and at home by assessing gas exchange, lung mechanics and the interaction between the patient… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Respiratory Failure, Non-invasive Ventilation
- What is being tested?
- Non-invasive ventilation
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2024to 1 Dec 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: COPD patients with chronic hypercapnic respiratory failure needing chronic NIV will be included
Who may be able to join
- COPD patients indicated for chronic home NIV
Who cannot join
- not able to read the written information and/or sign the informed consent form
- no possibility to perfrom measurements at home
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
UMCG
Groningen
Marieke Duiverman, MD PhD, +31503613200, m.l.duiverman@umcg.nl
About this study
The aim of the data collection is to create an advanced reliable method to remotely monitor patient on chronic home non-invasive ventilation (NIV), both regarding ventilatory efficacy and patient comfort, both in the hospital and at home by assessing gas exchange, lung mechanics and the interaction between the patient and the ventilator.
For this purpose, we will set-up of databank of synchronously acquired datasets of already standard care monitored parameters during NIV (transcutaneous monitoring of gas exchange; ventilator data including data on PVA), and newly non-invasively acquired data on patient effort (EMG, patient ratings) and lung (hyper)inflation (EIT), during the set-up and follow-up of standard care chronic NIV.
Read the detailed description
Can be provided on request as the registry rules are no in Dutch
- Being tested
- Non-invasive ventilation
- Keywords
- Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilationDevice
NIV as in standard care
| Study group | Role | What they receive |
|---|---|---|
| COPD patients with Chronic Respiratory Failure | Not described Receives: Device: Non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gas exchange
Transcutaneous monitoring of gas exchange
Measured: baseline
Gas exchange
Transcutaneous monitoring of gas exchange
Measured: 2 months
Gas exchange
Transcutaneous monitoring of gas exchange
Measured: 4 months
Gas exchange
Transcutaneous monitoring of gas exchange
Measured: 6 months
Patient comfort
Patient comfort assessed by VAS scale
Measured: baseline
Patient comfort
Patient comfort assessed by VAS scale
Measured: 2 months
Patient comfort
Patient comfort assessed by VAS scale
Measured: 4 months
Patient comfort
Patient comfort assessed by VAS scale
Measured: 6 months
AECOPD
Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics)
Measured: 2 months, 4 months, 6 months
AECOPD
Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics)
Measured: 2 months
AECOPD
Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics)
Measured: 4 months
Hospitalisations for AECOPD
Hospitalisations for acute exacerbations of COPD
Measured: 6 months
Sleep quality
Sleep quality assessing sleep depth and sleep stages
Measured: 2 months
Sleep quality
Sleep quality assessing sleep depth and sleep stages
Measured: 4 months
Sleep quality
Sleep quality assessing sleep depth and sleep stages
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Dec 2024
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente, Löwenstein BV, Vivisol, Sencure BV
- Responsible party
- Sponsor
- Investigators
- Marieke L Duiverman, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756387
- Sponsor's protocol ID
- 16013
- Acronym
- NOCTIVENT
- Status last verified
- Jul 2026
- First submitted
- 13 Feb 2023
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach
- ClinicalTrials.gov ID
- NCT05756387
- Acronym / sponsor ID
- NOCTIVENT / 16013
- Keywords
- Monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- University of Twente, Löwenstein BV, Vivisol, Sencure BV
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 6 Mar 2023 (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.
The aim of the data collection is to create an advanced reliable method to remotely monitor patient on chronic home non-invasive ventilation (NIV), both regarding ventilatory efficacy and patient comfort, both in the hospital and at home by assessing gas exchange, lung mechanics and the interaction between the patient and the ventilator.
For this purpose, we will set-up of databank of synchronously acquired datasets of already standard care monitored parameters during NIV (transcutaneous monitoring of gas exchange; ventilator data including data on PVA), and newly non-invasively acquired data on patient effort (EMG, patient ratings) and lung (hyper)inflation (EIT), during the set-up and follow-up of standard care chronic NIV.
Detailed description
Can be provided on request as the registry rules are no in Dutch
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients with Chronic Respiratory Failure | – | Device: Non-invasive ventilation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- COPD patients with chronic hypercapnic respiratory failure needing chronic NIV will be included
Key inclusion criteria (1 listed)
- COPD patients indicated for chronic home NIV
Key exclusion criteria (2 listed)
- not able to read the written information and/or sign the informed consent form
- no possibility to perfrom measurements at home
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 |
|---|---|---|
| Non-invasive ventilationNIV as in standard care | Device | COPD patients with Chronic Respiratory Failure |
Primary outcome
Gas exchange
Time frame: baseline
Transcutaneous monitoring of gas exchange
Gas exchange
Time frame: 2 months
Transcutaneous monitoring of gas exchange
Gas exchange
Time frame: 4 months
Transcutaneous monitoring of gas exchange
Gas exchange
Time frame: 6 months
Transcutaneous monitoring of gas exchange
Patient comfort
Time frame: baseline
Patient comfort assessed by VAS scale
Patient comfort
Time frame: 2 months
Patient comfort assessed by VAS scale
Patient comfort
Time frame: 4 months
Patient comfort assessed by VAS scale
Patient comfort
Time frame: 6 months
Patient comfort assessed by VAS scale
AECOPD
Time frame: 2 months, 4 months, 6 months
Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics)
AECOPD
Time frame: 2 months
Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics)
AECOPD
Time frame: 4 months
Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics)
Hospitalisations for AECOPD
Time frame: 6 months
Hospitalisations for acute exacerbations of COPD
Sleep quality
Time frame: 2 months
Sleep quality assessing sleep depth and sleep stages
Sleep quality
Time frame: 4 months
Sleep quality assessing sleep depth and sleep stages
Sleep quality
Time frame: 6 months
Sleep quality assessing sleep depth and sleep stages
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Respiratory Failure
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Recruiting
Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit
Chronic Respiratory Failure, Acute Respiratory Failure
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
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.
Marieke L Duiverman principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Respiratory Failure and Non-invasive Ventilation, run by University Medical Center Groningen at 1 site in Netherlands.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Jul 2026. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marieke L Duiverman, MD PhD (0031503613200, m.l.duiverman@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gas exchange (time frame: baseline). The study lists 15 primary outcomes in all. 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 Jul 2026.