An interventional study of F&P Mask in Chronic Respiratory Conditions and Obstructive Sleep Apnea (OSA), sponsored by Fisher and Paykel Healthcare. Not yet recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Fisher and Paykel Healthcare · Not applicable, Interventional, and Treatment
This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\&P mask in a home environment.
Exclusion Criteria:
Single-arm, non-randomised, open-label
Device: F&P Mask
PAP/NIV Therapy Mask
Therapeutic Efficacy
Determined by Apnea-Hypopnea Index (AHI) recorded on PAP therapy machines after 14 days of use. The Apnea-Hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe AHI is measured by dividing the total number of recorded apneas (complete breathing stops) and hypopneas (shallow breathing episodes) by the total number of hours a person slept during an overnight sleep study or using a PAP device. Higher AHI values represent worse outcomes. There is no maximum theoretical index score.
Time frame: Baseline and 14±5 days
Epworth Sleepiness Scale
All relevant time points used in the calculation in the Time Frame (e.g., baseline and 14±5 days). Note: change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 14±5 days minus value at baseline). Change between two time points is reported. Scale range: 0 (minimum score) to 24 (maximum score) (higher scores represent worse outcomes)
Time frame: 14±5 days
Patient and Clinical Global Impression (PGI/CGI)
Determined by Patient Global Impression (PGI) and Clinical Global Impression (CGI) assessments completed at baseline and Day 14. Baseline symptom severity is assessed using a 6-point scale (1 = No symptoms to 6 = Very severe symptoms). Change from baseline is assessed using a 7-point scale (1 = Very much better to 7 = Very much worse; 4 = No change). Higher severity scores indicate worse symptoms. For change assessments, lower scores indicate improvement and higher scores indicate worsening. PGI is completed by the patient and CGI is completed by the investigator/clinician.
Time frame: Baseline and 14±5 days
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Fisher and Paykel Healthcare