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NCT Number: NCT07826429

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

This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F&P Licorice mask in a home environment.

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Key information

Conditions

Chronic Respiratory Conditions Apnea Dyssomnias Nervous System Diseases Obstructive Sleep Apnea (OSA) Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

F&P Licorice Mask

Device

PAP/NIV Therapy Mask

Primary outcomes

  1. Therapeutic Efficacy

    Time frame: Baseline and 14±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.

  2. Epworth Sleepiness Scale

    Time frame: 14±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)

  3. Patient and Clinical Global Impression (PGI/CGI)

    Time frame: Baseline and 14±5 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Subbarao Potharaju

CONTACT

[email protected]

+1 800-792-3912

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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