Chronic Respiratory ConditionsNCT07826429
Evaluation of the F&P Mask, US, 2026
A study testing F&P Licorice Mask in people with Chronic Respiratory Conditions and Obstructive Sleep Apnea (OSA), run by Fisher and Paykel Healthcare at 1 site in United States.
Trial summary
This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\&P PAP mask in a home environment. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Respiratory Conditions, Obstructive Sleep Apnea (OSA)
- What is being tested?
- F&P Licorice Mask
- 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
- 28 Sep 2026to 21 Jun 2027
- Phase
- Interventional
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
- Are ≥22 years of age
- Weigh ≥66 pounds
- Have been prescribed PAP/NIV therapy by a physician
- Are an existing PAP/NIV therapy mask user with ≥3 months of use prior to enrolment in the clinical investigation*
- Are compliant with PAP/NIV therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical investigation
- Are fluent in spoken and written English
- Possess the capacity to provide informed consent
Who cannot join
- Are intolerant to PAP/NIV therapy
- Possess, or suffer from, anatomical or physiological conditions which make PAP/NIV therapy inappropriate
- Are required to use PAP/NIV therapy for >12 hours per day or for extensive periods, not including sleep or naps
- Are trying to get pregnant, are pregnant, or think they may be pregnant
- Have an IPAP pressure of >30 cmH2O if on BPAP
- Use a PAP/NIV therapy device for the delivery of medicines, except supplemental O2
- Use a PAP/NIV therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the clinical investigation site
- Have a history of light-induced seizures (for optional anthropometric scan only)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clayton Sleep Institute
St Louis, Missouri, 63123
Matthew Uhles, +1 314-645-5855, UhlesM@claytonsleep.com
About this study
Official title: Evaluation of the F&P PAP Mask, US, 2026
This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\&P PAP mask in a home environment.
- Being tested
- F&P Licorice Mask
- 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 Licorice MaskDevice
PAP/NIV Therapy Mask
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Single-arm, non-randomised, open-label Receives: Device: F&P Licorice Mask |
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 and 14±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: 14±5 days
Patient and Clinical Global Impression (PGI/CGI)
Determined by Patient Global Impression (PGI) and Clinical Global Impression (CGI) assessments completed at baseline and Day 14. Baseline symptom severity is assessed using a 6-point scale (1 = No symptoms to 6 = Very severe symptoms). Change from baseline is assessed using a 7-point scale (1 = Very much better to 7 = Very much worse; 4 = No change). Higher severity scores indicate worse symptoms. For change assessments, lower scores indicate improvement and higher scores indicate worsening. PGI is completed by the patient and CGI is completed by the investigator/clinician.
Measured: Baseline and 14±5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start28 Sep 2026 (estimated)
- Primary completion21 Apr 2027 (estimated)
- Study completion21 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory ConditionsStudies of the same condition, open and under way.
- 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 (estimated)
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
- NCT07826429
- Sponsor's protocol ID
- CIA-367
- Status last verified
- Oct 2026
- First submitted
- 13 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No