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OpenTrials
Completed

NCT Number: NCT04848012

Efficacy of an Advanced Auto-titrating NIV in COPD

Patients with chronic obstructive pulmonary disease (COPD) can eventually progress to respiratory failure, where they cannot adequately exchange oxygen and carbon dioxide, leading to worsening breathlessness, frequent hospitalisations and death. Non-invasive ventilation (NIV) is a ventilator therapy that is used in COPD patients who suffer from respiratory failure. Studies have demonstrated that using NIV at night regularly can result in improved clinical outcomes.

Adherence to this therapy is variable, however. This can be due to poor synchrony between the device and the lungs. A novel ventilator has been designed that delivers NIV but is also incorporated with technology to assess for aberrations in respiratory physiology and correct them, breath-by-breath.

The investigators aim to assess the efficacy, safety and tolerability of this novel ventilator. The primary research question is whether the novel ventilator can improve adherence to therapy, when compared with the usual ventilator.

Patients with COPD who use ventilation at home will be screened for inclusion in the study. Participation will involve a screening visit, and a further two visits to the Lane Fox Respiratory Unit. The first will require a two-night admission and the second a single-night admission. They will undergo detailed assessment of their daytime and overnight respiratory and sleep physiology during these admissions. These visits will be separated by a six-week period during which they will be asked to use the novel ventilator at home.

Patients will be recruited into a sub-study to evaluate the performance of the ventilator in a daytime physiological assessment. This will involve detailed invasive physiological assessment of expiratory flow limitation and how the machine is able to adjust settings to optimise respiratory support.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guys and St Thomas NHS Foundation Trust

London, SE1 7EH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Patient Inclusion Criteria:

  • Age ≥ 18 years
  • BMI <30 kg/m¬2
  • Confirmed diagnosis of COPD
  • Currently using domiciliary NIV with average reported compliance of at least 3hours
  • Ability to provide informed consent
  • Medical stability confirmed by recruiting physician
  • Free of exacerbations for at least 2 weeks prior to enrolment
  • Presence of expiratory flow limitation on forced oscillation technique criteria

Exclusion criteria

  • Current acute illness as determined by recruiting physician e.g. upper respiratory tract infection
  • Presence of major medical comorbidity, e.g. severe heart failure (LVEF <30%), active malignancy, end-stage renal failure (CKD 4), and neuromuscular disease
  • Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
  • Psychosocial factors that would prevent compliance with study protocol

Healthy participant inclusion criteria:

  • Age ≥ 18 years
  • No expiratory flow limitation on forced oscillation testing
  • No acute illness on study day
  • Ability to provide informed consent

Treatment and study plan

Auto-titrating non-invasive ventilation

Device

A non-invasive ventilator designed to auto-adjust the expiratory positive airway pressure according to expiratory flow limitation, measured using the forced oscillation technique.

Primary outcomes

  1. Adherence to ventilation therapy

    Time frame: 6 weeks

    Number of hours spent on nocturnal ventilation therapy

Secondary outcomes

  1. Mean nocturnal transcutaneous carbon dioxide level

    Time frame: 1 night during single night admission

    Mean nocturnal transcutaneous carbon dioxide level measured on single night admission

  2. Maximal nocturnal transcutaneous carbon dioxide level

    Time frame: 1 night during single night admission

    Maximal nocturnal transcutaneous carbon dioxide level measured on single night admission

  3. Sleep parameters

    Time frame: 1 night during single night admission

    Sleep efficiency, measured by polysomnography

  4. Sleep parameters

    Time frame: 1 night during single night admission

    Wake after sleep onset, measured by polysomnography

  5. Sleep parameters

    Time frame: 1 night during single night admission

    Time in rapid eye movement/non rapid eye movement sleep, measured by polysomnography

  6. Sleep parameters

    Time frame: 1 night during single night admission

    Apnoea/hypopnoea index, measured by polysomnography

  7. Sleep parameters

    Time frame: 1 night during single night admission

    4 per cent oxygen desaturation index, measured by polysomnography

  8. Inspiratory capacity

    Time frame: 6 weeks

    Inspiratory capacity following 6 weeks of each NIV device

  9. Health-related quality of life

    Time frame: 6 weeks

    Measured using COPD Assessment Test

  10. Health-related quality of life

    Time frame: 6 weeks

    Measured using Severe Respiratory Insufficiency Questionnaire

  11. Daytime physical activity

    Time frame: 2 weeks

    Measured using wrist actigraphs during the final 2 weeks of each 6 week arm

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Official study title

Clinical Validation, Safety & Efficacy Study of an Advanced Auto-titrating Non-invasive Ventilator in Patients With Severe Chronic Obstructive Pulmonary Disease

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2021
Registry last updated
Jun 4, 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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