Last updated: May 7, 2025
Sponsor: Fisher and Paykel Healthcare
Overall Status: Active - Recruiting
Phase
N/A
Condition
Copd (Chronic Obstructive Pulmonary Disease)
Treatment
NIV mask B
NIV mask A
Clinical Study ID
NCT06682286
U1111-1308-1838
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion Criteria:
Uncontrolled sleep apnea (Apnea-hypopnea index (AHI) over 15 events/hour offpersonal NIV device data)
Prescribed IPAP above 25 cmH2O
Self-reported pregnancy
Allergic to adhesive of the sensors
Self-reported cold/flu symptoms
Study Design
Total Participants: 40
Treatment Group(s): 2
Primary Treatment: NIV mask B
Phase:
Study Start date:
January 24, 2025
Estimated Completion Date:
September 30, 2025
Study Description
Connect with a study center
Fisher and Paykel Healthcare Sleep Laboratory
Auckland, 2013
New ZealandActive - Recruiting
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