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

September 3, 2025 updated by: Fisher and Paykel Healthcare
The purpose of this clinical investigation is to evaluate the performance and safety of the F&P Caramel nasal mask in a home environment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63123
        • Clayton Sleep Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single-arm, non-randomised open-label
Device: F&P Caramel
Nasal mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic Efficacy
Time Frame: 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.
Baseline and14±5 days
Epworth Sleepiness Scale
Time Frame: 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)
Baseline and14±5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisher and Paykel Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2023

Primary Completion (Actual)

December 11, 2023

Study Completion (Actual)

June 11, 2024

Study Registration Dates

First Submitted

September 24, 2023

First Submitted That Met QC Criteria

September 24, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIA-337

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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