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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
F&P Toffee
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio Sleep Medicine Institute

Outcomes

Primary Outcome Measures

Apnea-Hypopnea Index
Acceptable maintenance or lower (improved score) from baseline. Scores below 5 indicate a better outcome.
Epworth Sleepiness Scale
Acceptable maintenance or lower (improved score) from baseline. Scores below 11 indicate a better outcome.

Secondary Outcome Measures

Full Information

First Posted
October 6, 2022
Last Updated
September 11, 2023
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT05573763
Brief Title
Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022
Official Title
Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
December 2, 2022 (Actual)
Study Completion Date
June 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
F&P Toffee
Intervention Description
Nasal pillows mask
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index
Description
Acceptable maintenance or lower (improved score) from baseline. Scores below 5 indicate a better outcome.
Time Frame
14±5 days
Title
Epworth Sleepiness Scale
Description
Acceptable maintenance or lower (improved score) from baseline. Scores below 11 indicate a better outcome.
Time Frame
14±5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ohio Sleep Medicine Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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