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OpenTrials
Completed

NCT Number: NCT05573763

Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022

The purpose of this clinical investigation is to evaluate the performance and safety of the F&P Toffee nasal pillows mask in a home environment.

Completed

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases 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

Ohio Sleep Medicine Institute

Columbus, Ohio, 43017, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 pillows mask users with at ≥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

Exclusion criteria

  • 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 >25 cmH2O if on BPAP
  • Persons who use a PAP therapy device for the delivery of medicines, except supplemental O2
  • 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

Treatment and study plan

F&P Toffee

Device

Nasal pillows 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"

  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)

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Oct 10, 2022
Registry last updated
Sep 22, 2025

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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