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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFisher and Paykel Healthcare

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

Qualifiers

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

Treatments tested in this trial

  • Investigational Mask
  • Conventional mask

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators