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

NCT06060717 | Completed Results FDA Device

• 1 other identifier: CIA-337
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and14±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)

  Baseline and14±5 days

Study Arms (1)

Single-arm, non-randomised open-label

OTHER

Device: F&P Caramel

Interventions

F&P Caramel DEVICE

Nasal mask

Single-arm, non-randomised open-label

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Kelly Tay
• Organization: Fisher & Paykel Healthcare Ltd

kelly.tay@fphcare.co.nz

+64 9-282-9734

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: September 29, 2023
• Study Start: November 27, 2023
• Primary Completion: December 11, 2023
• Study Completion: June 11, 2024
• Last Updated: September 23, 2025
• Results First Posted: September 23, 2025

Record last verified: 2025-09

Locations

US (1)