Evaluation of the F&P Caramel Nasal Mask, US, 2023

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT06060717
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

The purpose of this clinical investigation is to evaluate the performance and safety of the F\&P Caramel nasal mask in a home environment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-24
• Study First Submitted QC: 2023-09-24
• Study First Posted: 2023-09-29
• Study Start: 2023-11-27
• Primary Completion: 2023-12-11
• Study Completion: 2024-06-11
• Results First Submitted: 2025-08-17
• Status Verified: 2025-09
• Results First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Results First Posted: 2025-09-23
• Last Update Posted: 2025-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Persons who are ≥22 years of age
• Persons who weigh ≥66 pounds
• Persons who have been prescribed PAP therapy by a physician
• Persons who are existing nasal mask or sub-nasal mask users with ≥3 months of use prior to enrolment in the clinical trial
• Persons who are compliant with PAP therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical trial
• Persons who are fluent in spoken and written English
• Persons who possess the capacity to provide informed consent

Exclusion Criteria

• Persons who are intolerant to PAP therapy
• Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
• Persons who are required to use PAP therapy for >12 hours per day or for extensive periods, not including sleep or naps
• Persons who are trying to get pregnant, are pregnant, or think they may be pregnant
• Persons who have an IPAP pressure of >30 cmH2O if on BPAP
• Persons who use a PAP therapy device for the delivery of medicines, except supplemental oxygen
• Persons who use a PAP therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the investigation site

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Therapeutic Efficacy	Baseline and14±5 days	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	Baseline and14±5 days	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)

Trial Locations

Locations (1)

Clayton Sleep Institute; 🇺🇸 St Louis, Missouri, United States