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

Not Applicable

Not yet recruiting

• 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

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

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• 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
Apnea-Hypopnea Index	14±5 days	Acceptable maintenance or lower (improved score) from baseline. Scores below 5 indicate a better outcome.
Epworth Sleepiness Scale	14±5 days	Acceptable maintenance or lower (improved score) from baseline. Scores below 11 indicate a better outcome.