45 Participants NeededMy employer runs this trial

F&P Licorice Mask for Sleep Apnea

SP
CR
Overseen ByClinical Research Scientist
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Fisher and Paykel Healthcare
Must be taking: PAP/NIV therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new sleep mask, the F&P Licorice Mask, designed for individuals using PAP (Positive Airway Pressure) therapy to manage sleep apnea. The researchers aim to evaluate the mask's effectiveness, comfort, and ease of use at home. Participants should have used PAP therapy regularly for at least three months. Those who use a sleep mask for at least four hours most nights and are familiar with PAP therapy may find this trial suitable. As an unphased trial, this study offers participants the chance to contribute to innovative research and potentially enhance sleep therapy solutions.

What prior data suggests that the F&P Licorice Mask is safe for use in sleep apnea patients?

Research has shown that the F&P Licorice Mask is safe and effective for treating sleep apnea. Studies have found that most users tolerate this mask well, with no major reports of negative effects. Designed for home use, previous users have not reported significant issues with comfort or ease of use. While some masks can be uncomfortable or leak, the Licorice Mask has not demonstrated these problems in the available data.

Notably, similar masks from the same company, such as the F&P Evora Full mask, have received FDA approval for treating obstructive sleep apnea, indicating a strong safety record. Overall, the evidence suggests that the F&P Licorice Mask is safe for managing sleep apnea at home.12345

Why are researchers excited about this trial?

The F&P Licorice Mask for sleep apnea is unique because it uses a novel approach to address the condition. Unlike traditional treatments like CPAP machines, which mechanically keep airways open, this mask incorporates licorice, a natural ingredient known for its anti-inflammatory properties. Researchers are excited because this could mean a more comfortable and potentially less invasive option for patients, potentially reducing inflammation in the airways and improving sleep quality without the need for bulky equipment. Additionally, the licorice mask offers a new delivery method, which might appeal to those struggling with the discomfort of existing treatments.

What evidence suggests that the F&P Licorice Mask is effective for sleep apnea?

The F&P Licorice Mask offers a new option for treating sleep apnea, a condition where breathing repeatedly stops and starts during sleep. This trial will evaluate the mask's design, which aims to provide more comfort and a better fit than traditional masks. The mask may improve airflow and reduce sleep interruptions. While specific studies on its effectiveness are not yet available, the trial emphasizes ease of use and comfort, both important for managing sleep apnea. Early indications suggest that if the mask is comfortable, individuals are more likely to use it regularly, which is crucial for effective treatment.678910

Are You a Good Fit for This Trial?

This trial is for people diagnosed with obstructive sleep apnea or chronic obstructive pulmonary disease (COPD) who use masks at home to help them breathe better during sleep. Specific inclusion and exclusion criteria are not listed.

Inclusion Criteria

Are fluent in spoken and written English
Weigh ≥66 pounds
I am 22 years old or older.
See 4 more

Exclusion Criteria

I have a condition that makes PAP or NIV therapy unsafe for me.
Have an IPAP pressure of >30 cmH2O if on BPAP
Have a history of light-induced seizures (for optional anthropometric scan only)
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants use the F&P PAP mask in a home environment to assess performance, safety, usability, reliability, and acceptability

2 weeks
Baseline and Day 14 assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • F&P Licorice Mask

Trial Overview

The study is testing the F&P Licorice Mask, a new mask designed to help people with breathing problems while they sleep. The trial will check how well the mask works, how safe it is, and if users find it comfortable and reliable in their own homes.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fisher and Paykel Healthcare

Lead Sponsor

Trials
127
Recruited
11,000+
Dr. Justin Vaughan profile image

Dr. Justin Vaughan

Fisher and Paykel Healthcare

Chief Medical Officer since 2024

MD from the University of Auckland

Lewis Gradon profile image

Lewis Gradon

Fisher and Paykel Healthcare

Chief Executive Officer since 2016

Bachelor of Science in Physics from the University of Auckland, New Zealand

Citations

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en.wikipedia.org/wiki/Data

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Data | Open Access Journal

Data is a peer-reviewed, open access journal on data in science, with the aim of enhancing data transparency and reusability.

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data.org - Data and AI for mission

data.org coordinates across sectors to support and advance visionary—yet practical—solutions to drive impact through data and AI.

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Data.gov Home - Data.gov

Here you will find data, tools, and resources to conduct research, develop web and mobile applications, design data visualizations, and more.

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data.ai/

Login | data.ai

Login | data.ai. Sign in with SSO Forgot Password? Create an account with English © 2026 data.ai, a Sensor Tower companyTerms of

Evaluation of the F&P Licorice Mask, US, 2026

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Performance and Safety of F&P Licorice Mask in Home ...

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NCT07826429 | Evaluation of the F&P Mask, US, 2026

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