Assessment of Breathing Pattern During NIV

Fisher & Paykel Healthcare

Status: Enrolling

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

Treatments: Other: NIV mask A; Other: NIV mask B

Study type: Interventional

Funder types: Industry

Identifiers

NCT06682286

U1111-1308-1838

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Breathing route assessment: Awake and off pressure support

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: NIV mask B

Other: NIV mask A

Breathing route assessment: Asleep and on pressure support

Experimental group

Description:

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

Treatment:

Other: NIV mask B

Other: NIV mask A