Status:
NOT_YET_RECRUITING
The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.
Lead Sponsor:
Fisher and Paykel Healthcare
Conditions:
COPD (Chronic Obstructive Pulmonary Disease)
Obesity Hypoventilation Syndrome (OHS)
Eligibility:
All Genders
18+ years
Phase:
NA
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 Ve...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06972589
Start Date
May 1 2025
End Date
April 1 2026
Last Update
May 15 2025
Active Locations (1)
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1
Fisher and Paykel Healthcare Sleep Laboratory
Auckland, New Zealand, 2013