Obstructive Sleep ApneaNCT06060717
Evaluation of the F&P Caramel Nasal Mask, US, 2023
A study testing F&P Caramel in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- F&P Caramel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2023to 11 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- F&P Caramel
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F&P CaramelDevice
Nasal mask
| Study group | Role | What they receive |
|---|---|---|
| Single-arm, non-randomised open-label | Other | Not described Receives: Device: F&P Caramel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Baseline and14±5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start27 Nov 2023
- Primary completion11 Dec 2023
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Fisher and Paykel HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060717
- Sponsor's protocol ID
- CIA-337
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2023
- Last updated
- 23 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the F&P Caramel Nasal Mask, US, 2023
- ClinicalTrials.gov ID
- NCT06060717
- Acronym / sponsor ID
- CIA-337
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Posted 23 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm, non-randomised open-label | Other | Device: F&P Caramel |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F&P CaramelNasal mask | Device | Single-arm, non-randomised open-label |
Primary outcome
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.
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F&P Caramel in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic Efficacy (time frame: Baseline and14±5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.