Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06682286

Breathing Route in COPD and OHS Patients on Long-term Home Non-invasive Ventilation: An Experimental Study

Led by Fisher and Paykel Healthcare · Updated on 2025-05-11

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying breathing patterns in people with Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS) who use long-term non-invasive ventilation (NIV) at home. The aim is to better understand how the route of breathing affects comfort and use of breathing masks, since current knowledge mostly comes from studies on obstructive sleep apnea (OSA), a different condition. This trial explores whether findings from OSA apply to COPD and OHS, conditions that affect breathing differently. Participants will undergo a series of breathing assessments while awake and asleep using two types of NIV masks: a bridge-free face mask and a full face mask. The study includes a 30-minute recording of natural breathing without NIV, followed by two 30-minute sessions wearing each mask while awake on prescribed pressure support settings. Participants will then spend the night in a sleep laboratory using these masks during sleep, with mask changes after a minimum of 60 minutes. Throughout the study, researchers will record breathing routes during awake and asleep periods with and without pressure support. Participants will have overnight sleep studies and mask usage monitored to assess how different masks influence breathing. The study measures include breathing route while awake off pressure support, while awake on pressure support, and while asleep on pressure support, totaling about 12 hours of observation. The research team also monitors safety and comfort during the study.

CONDITIONS

Brief Title

Assessment of Breathing Pattern During NIV

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Prescribed nocturnal non-invasive ventilation (NIV) for COPD or Obesity Hypoventilation Syndrome (OHS)
  • Able to complete an overnight sleep study
  • Comfortable sleeping on a standard double bed
  • Capacity to provide informed consent
Not Eligible

You will not qualify if you...

  • Uncontrolled sleep apnea with apnea-hypopnea index over 15 events/hour off personal NIV device data
  • Prescribed inspiratory positive airway pressure (IPAP) above 25 cmH2O
  • Self-reported pregnancy
  • Allergy to adhesive used in sensors
  • Self-reported cold or flu symptoms

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Breathing Assessment While Awake

Duration - Approximately 2 hours

Participants have their breathing route recorded while lying on their backs without NIV for about 30 minutes. They then use two different non-invasive ventilation (NIV) masks with pressure support, each mask used for about 30 minutes while awake.

1 in-person visit including multiple 30-minute recordings

Overnight Sleep Study with NIV

Duration - Overnight (approximately 8 hours)

Participants spend the night in a sleep laboratory using NIV therapy with the last mask used during the awake test. After at least 60 minutes of recording, participants are awakened to switch back to the first mask, then allowed to sleep uninterrupted for the rest of the night.

1 overnight visit in the sleep laboratory

Trial Site Locations

Total: 1 location

1

Fisher and Paykel Healthcare Sleep Laboratory

Auckland, New Zealand, 2013

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Research Team

V

Valeria Mereacre, PhD Physiology

J

Jessica Fogarin

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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