Assessment of Breathing Pattern During NIV

NCT06682286 | Recruiting

• 1 other identifier: U1111-1308-1838
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Obesity Hypoventilation Syndrome (OHS)

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Breathing route assessment: Awake and off pressure support

NO INTERVENTION

Breathing route will be recorded in awake participants without the use of NIV for approximately 30 min.

Breathing route assessment: Awake and on pressure support

EXPERIMENTAL

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; Other: NIV mask B

Breathing route assessment: Asleep and on pressure support

EXPERIMENTAL

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; Other: NIV mask B

Interventions

NIV mask A OTHER

Bridge free face mask

Breathing route assessment: Asleep and on pressure support; Breathing route assessment: Awake and on pressure support

NIV mask B OTHER

Full face mask

Breathing route assessment: Asleep and on pressure support; Breathing route assessment: Awake and on pressure support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

Fisher and Paykel Healthcare Sleep Laboratory

Auckland, 2013, New Zealand

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• William Good, Medical degree

  Middlemore Hospital, New Zealand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valeria Mereacre, PhD Physiology

CONTACT

0064 2102819036; val.mereacre@fphcare.co.nz

Jessica Fogarin

CONTACT

jess.fogarin@fphcare.co.nz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Crossover study where the breathing route of each participant will be assessed off- and on NIV. Additionally, the breathing route of each participant on NIV will be investigated during sleep and in awake state.

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 12, 2024
• Study Start: January 24, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)