Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT06972589

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

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

Full registry criteria

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

Treatments and study arms

Investigational Mask

Device

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

Conventional mask

Device

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

Primary outcomes

Change in respiratory rate4 hours

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Fisher and Paykel Healthcare Sleep Laboratory🇳🇿 Auckland, New Zealand

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Jessica FogarinContact

Email · Call 7327

Study contactContact

Valeria Mereacre, PhD PhysiologySub Investigator