About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
Investigational Mask
DeviceWear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep.
Conventional mask
DeviceWear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep.
Treatment groups
Trial outcomes
Primary outcomes
Change in respiratory rate
Sponsors and contacts
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