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NCT Number: NCT05756387

Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach

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.

Recruiting

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Key information

Conditions

Chronic Respiratory Failure Non-invasive Ventilation

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Can be provided on request as the registry rules are no in Dutch

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COPD patients indicated for chronic home NIV

Exclusion criteria

  • not able to read the written information and/or sign the informed consent form
  • no possibility to perfrom measurements at home

Treatment and study plan

Non-invasive ventilation

Device

NIV as in standard care

Primary outcomes

  1. Gas exchange

    Time frame: baseline

    Transcutaneous monitoring of gas exchange

  2. Gas exchange

    Time frame: 2 months

    Transcutaneous monitoring of gas exchange

  3. Gas exchange

    Time frame: 4 months

    Transcutaneous monitoring of gas exchange

  4. Gas exchange

    Time frame: 6 months

    Transcutaneous monitoring of gas exchange

  5. Patient comfort

    Time frame: baseline

    Patient comfort assessed by VAS scale

  6. Patient comfort

    Time frame: 2 months

    Patient comfort assessed by VAS scale

  7. Patient comfort

    Time frame: 4 months

    Patient comfort assessed by VAS scale

  8. Patient comfort

    Time frame: 6 months

    Patient comfort assessed by VAS scale

  9. 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)

  10. 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)

  11. 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)

  12. Hospitalisations for AECOPD

    Time frame: 6 months

    Hospitalisations for acute exacerbations of COPD

  13. Sleep quality

    Time frame: 2 months

    Sleep quality assessing sleep depth and sleep stages

  14. Sleep quality

    Time frame: 4 months

    Sleep quality assessing sleep depth and sleep stages

  15. Sleep quality

    Time frame: 6 months

    Sleep quality assessing sleep depth and sleep stages

Study contacts

Contact information is provided by the study sponsor or research team.

Marieke L Duiverman, MD PhD

CONTACT

[email protected]

0031503613200

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Löwenstein BV
  • Sencure BV
  • University of Twente
  • Vivisol

Registry information

Acronym: NOCTIVENT

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 6, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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