Evaluation of the F&P Mask, US, 2026

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.

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)

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.