Skip to content

The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.

The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06972589
Enrollment
20
Registered
2025-05-15
Start date
2025-05-31
Completion date
2026-04-30
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

Chronic obstructive pulmonary disease (COPD) and obesity hypoventilation syndrome (OHS) are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV) delivers positive pressures via an interface such as a face mask and 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. However, poor performance of the NIV mask and poor comfort can make NIV therapy harder to tolerate. This study will assess if a new mask helps to improve the breathing of people on NIV and normalize blood gases.

Detailed description

Participants are moved to the sleep laboratory for the night where they are provided with beds. * The participants are put on their prescribed airway pressure support with the first randomized mask. * After at least 60 minutes of recording, participants are awakened to switch back to the second mask. They are then allowed to sleep uninterrupted for the rest of the night.

Interventions

DEVICEInvestigational Mask

Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep.

DEVICEConventional mask

Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep.

Sponsors

Fisher and Paykel Healthcare
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 * Allergic to adhesive of the sensors * Self-reported cold/flu symptoms

Design outcomes

Primary

MeasureTime frame
Change in respiratory rate4 hours

Countries

New Zealand

Contacts

Primary ContactValeria Mereacre, PhD Physiology
val.mereacre@fphcare.co.nz02102819036
Backup ContactJessica Fogarin
jess.fogarin@fphcare.co.nz

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026