Assessment of Breathing Pattern During NIV

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity Hypoventilation Syndrome (OHS); COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Other: NIV mask A; Other: NIV mask B

Detailed Description

• 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valeria Mereacre, PhD Physiology; Phone Number: 0064 2102819036; Email: val.mereacre@fphcare.co.nz
• Study Contact Backup: Name: Jessica Fogarin; Email: jess.fogarin@fphcare.co.nz

Study Locations

• New Zealand
  • Auckland, New Zealand, 2013
    • Recruiting
    • Fisher and Paykel Healthcare Sleep Laboratory
    • Contact: Jessica Fogarin; Phone Number: 7327; Email: jess.fogarin@fphcare.co.nz
    • Sub-Investigator: Valeria Mereacre
    • Principal Investigator: William R Good, Medical degree

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Breathing route assessment: Awake and off pressure support; Breathing route will be recorded in awake participants without the use of NIV for approximately 30 min.
Experimental: Breathing route assessment: Awake and on pressure support; Awake participants will be placed on their prescribed pressure support settings and will use two different non-invasive ventilation (NIV) masks, each for about 30 minutes.	Other: NIV mask A; Bridge free face mask; Other: NIV mask B; Full face mask
Experimental: Breathing route assessment: Asleep and on pressure support; Participants will be placed on their prescribed pressure support settings and will go to sleep. After 60 minutes, they will be awakened to change their mask. They will use two different non-invasive ventilation (NIV) masks, each for a minimum of 60 minutes	Other: NIV mask A; Bridge free face mask; Other: NIV mask B; Full face mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breathing route while on and off pressure support (awake)	Percent of time nose and mouth breathing in COPD and/or OHS patients while on and off pressure support.	4 hours
Breathing route while on pressure support (asleep)	Percent of time nose and mouth breathing in COPD and/or OHS patients while on pressure support during sleep.	8 hours
Mask type influence on breathing route (asleep and awake)	Percent of time nose and mouth breathing in COPD and/or OHS patients depending on the NIV mask type	12 hours

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: William Good, Medical degree, Middlemore Hospital, New Zealand

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 8, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Nutrition Disorders; Chronic Disease; Disease Attributes; Overnutrition; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Overweight; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Obesity; Respiratory Insufficiency; Sleep Apnea, Obstructive; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypoventilation; Obesity Hypoventilation Syndrome
• Other Study ID Numbers: U1111-1308-1838

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No