Recruiting

F&P Licorice Mask

Sponsor:

Fisher and Paykel Healthcare

Code:

NCT07826429

Conditions

Chronic Respiratory Conditions

Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

F&P Licorice Mask

Study Details

Brief summary:

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.

Conditions

Chronic Respiratory Conditions

Obstructive Sleep Apnea (OSA)

Study ID

NCT07826429

Start date

Sep 28, 2026

Status verified date

Oct, 2026

Completion date

Jun 21, 2027

Anticipated

Primary completion date

Apr 21, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Intervention

Single-arm, non-randomised, open-label

Interventions

F&P Licorice Mask

PAP/NIV Therapy Mask

Primary outcome measure

  • Therapeutic Efficacy [ Time Frame: Baseline and 14±5 days ]
  • Epworth Sleepiness Scale [ Time Frame: 14±5 days ]
  • Patient and Clinical Global Impression (PGI/CGI) [ Time Frame: Baseline and 14±5 days ]

Central Contacts and Locations

Central contacts

Clinical Research Scientist

+6421436485cpap.trial@fphcare.co.nz

Locations

Clayton Sleep Institute

Recruiting

St Louis, Missouri, United States, 63123

Contacts

Matthew Uhles

+1 314-645-5855UhlesM@claytonsleep.com

More Information

Sponsor

Fisher and Paykel Healthcare

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by Fisher and Paykel Healthcare on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.