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NCT Number: NCT06682286

Assessment of Breathing Pattern During NIV

COPD and OHS are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV), has been shown to improve breathing and reduce symptoms in patients with these conditions. Regular use of NIV can lead to better symptom management, improved quality of life, and reduced use of healthcare resources. The type of mask used for breathing support can greatly affect a patient's comfort and willingness to use it. For conditions like Obstructive Sleep Apnea (OSA), which is a physical blockage of the airway caused by the relaxation of the muscles of the throat, nasal masks are often used because they are comfortable and work well. But for breathing support in the hospital, full face masks are typically used because patients are having significant trouble breathing and tend to breathe through their mouth.

However, it's important to note that we don't yet fully understand the best way to provide breathing support for long-term NIV users, like COPD and OHS patients. The understanding of breathing route is currently only established for OSA. However, conditions like COPD affect the lungs and the overall system used for breathing, which is different from the throat blockage seen in OSA. So, the assumptions we make based on conditions like OSA may not apply to these other conditions. More research is needed to understand this better.

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Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Apnea Chronic Disease Disease Attributes Dyssomnias Hypoventilation Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity Hypoventilation Syndrome Obesity Hypoventilation Syndrome (OHS) Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fisher and Paykel Healthcare Sleep Laboratory

Auckland, 2013, New Zealand

Location status: Recruiting

Location contact

Jessica Fogarin

CONTACT

[email protected]

7327

Valeria Mereacre

SUB_INVESTIGATOR

William R Good, Medical degree

PRINCIPAL_INVESTIGATOR

About this study

  • Participants undergo PSG, lying on their backs while their breathing route is recorded for about 30 minutes.
  • The participants are then put on their prescribed airway pressure support with the first randomized mask, and their breathing is recorded again for 30 minutes.
  • The mask is switched to the second mask, and the same procedure is repeated.

Participants are then moved to the sleep laboratory for the night where they are provided with beds.

  • They continue 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. They are then allowed to sleep uninterrupted for the rest of the night.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age over 18 years
  • Prescribed nocturnal NIV for COPD or OHS
  • Able to complete an overnight sleep study
  • Comfortable to sleep on a standard double bed
  • Capacity to complete informed consent

Exclusion criteria

  • Uncontrolled sleep apnea (Apnea-hypopnea index (AHI) over 15 events/hour off personal NIV device data)
  • Prescribed IPAP above 25 cmH2O
  • Self-reported pregnancy
  • Allergic to adhesive of the sensors
  • Self-reported cold/flu symptoms

Treatment and study plan

NIV mask A

Other

Bridge free face mask

NIV mask B

Other

Full face mask

Primary outcomes

  1. Breathing route while on and off pressure support (awake)

    Time frame: 4 hours

    Percent of time nose and mouth breathing in COPD and/or OHS patients while on and off pressure support.

  2. Breathing route while on pressure support (asleep)

    Time frame: 8 hours

    Percent of time nose and mouth breathing in COPD and/or OHS patients while on pressure support during sleep.

  3. Mask type influence on breathing route (asleep and awake)

    Time frame: 12 hours

    Percent of time nose and mouth breathing in COPD and/or OHS patients depending on the NIV mask type

Study contacts

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

Jessica Fogarin

CONTACT

[email protected]

Valeria Mereacre, PhD Physiology

CONTACT

[email protected]

0064 2102819036

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
May 11, 2025

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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