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Evaluation of the Toffee Nasal and Toffee Nasal Pillows Mask in Home, USA, 2022

Primary Purpose

Obstructive Sleep Apnea

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

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Positive Airway Pressure Therapy

Eligibility Criteria

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

Inclusion Criteria:

  1. Persons who are ≥ 22 years of age
  2. Persons who weigh ≥ 66 lbs (30 kgs)
  3. Persons who have been prescribed PAP (APAP, BPAP or CPAP) therapy by a physician
  4. Persons who are compliant with PAP therapy for ≥ 4 hours per night for 70% of nights for at least two weeks prior to enrolment in the trial
  5. Persons who are currently using either a nasal, sub-nasal or nasal pillows mask
  6. Persons who have an IPAP pressure of < 20 cmH2O
  7. Persons who currently use a PAP therapy device with data recording capabilities
  8. Persons who are fluent in spoken and written English
  9. Persons who possess the capacity to provide informed consent

Exclusion Criteria:

  1. Persons who are intolerant to PAP therapy
  2. Persons who are required to use PAP therapy for more than 12 hours per day or for extensive periods other than sleep or naps
  3. Persons using full face masks
  4. Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
  5. Persons who are pregnant or think they may be pregnant
  6. Persons who use a PAP therapy machine for the delivery of medicines, except supplemental O2

Sites / Locations

  • Clinical Site Partners, LLC - DBA CSP Miami
  • Clayton Sleep Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

F&P Toffee Nasal and Toffee Nasal Pillows Mask

Arm Description

Participants will be placed in the experimental arm for 14 days, during which they will be using either the Toffee Nasal or Toffee Nasal Pillows mask for PAP therapy.

Outcomes

Primary Outcome Measures

Therapeutic Efficacy
The F&P Toffee Nasal and Toffee Nasal Pillows masks provides adequate PAP therapy when used in a home environment. This is an objective measure and is determined by the Apnea-Hypopnea Index recorded on PAP therapy machines after 14 days of use.

Secondary Outcome Measures

Comfort
The F&P Toffee Nasal and Toffee Nasal Pillows is comfortable during PAP therapy when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire after 14 days of use.

Full Information

First Posted
August 8, 2022
Last Updated
July 9, 2023
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT05496062
Brief Title
Evaluation of the Toffee Nasal and Toffee Nasal Pillows Mask in Home, USA, 2022
Official Title
Evaluation of the Toffee Nasal and Toffee Nasal Pillows Mask in Home, USA, 2022
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
October 7, 2022 (Actual)
Study Completion Date
April 30, 2024 (Anticipated)

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical investigation is designed to assess the F&P Toffee Nasal and Toffee Nasal Pillows masks in home for use during PAP therapy delivery. The objectives of the investigation are to assess therapeutic efficacy, safety and comfort.
Detailed Description
This clinical investigation is designed to assess the F&P Toffee Nasal and Toffee Nasal Pillows masks in home for use during PAP therapy delivery. A target recruitment goal of 45, current PAP therapy users per mask type (e.g. Nasal and Nasal Pillows) will be recruited to participate in this investigation to achieve a total sample of 90. The investigation will involve participation in a two week in home trial of the F&P Toffee Nasal or Toffee Nasal Pillows mask. The objectives of the investigation are to assess therapeutic efficacy, safety and comfort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Positive Airway Pressure Therapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
F&P Toffee Nasal and Toffee Nasal Pillows Mask
Arm Type
Experimental
Arm Description
Participants will be placed in the experimental arm for 14 days, during which they will be using either the Toffee Nasal or Toffee Nasal Pillows mask for PAP therapy.
Intervention Type
Device
Intervention Name(s)
F&P Toffee Nasal and Toffee Nasal Pillows Masks
Intervention Description
F&P Toffee Nasal and Toffee Nasal Pillows Masks are intended to be used within the traditional PAP therapy system and are designed to facilitate equivalent PAP therapeutic efficacy as defined by standard practice.
Primary Outcome Measure Information:
Title
Therapeutic Efficacy
Description
The F&P Toffee Nasal and Toffee Nasal Pillows masks provides adequate PAP therapy when used in a home environment. This is an objective measure and is determined by the Apnea-Hypopnea Index recorded on PAP therapy machines after 14 days of use.
Time Frame
After two weeks of use
Secondary Outcome Measure Information:
Title
Comfort
Description
The F&P Toffee Nasal and Toffee Nasal Pillows is comfortable during PAP therapy when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire after 14 days of use.
Time Frame
After two weeks of use

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 lbs (30 kgs) Persons who have been prescribed PAP (APAP, BPAP or CPAP) therapy by a physician Persons who are compliant with PAP therapy for ≥ 4 hours per night for 70% of nights for at least two weeks prior to enrolment in the trial Persons who are currently using either a nasal, sub-nasal or nasal pillows mask Persons who have an IPAP pressure of < 20 cmH2O Persons who currently use a PAP therapy device with data recording capabilities 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 are required to use PAP therapy for more than 12 hours per day or for extensive periods other than sleep or naps Persons using full face masks Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate Persons who are pregnant or think they may be pregnant Persons who use a PAP therapy machine for the delivery of medicines, except supplemental O2
Facility Information:
Facility Name
Clinical Site Partners, LLC - DBA CSP Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Clayton Sleep Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63123
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Evaluation of the Toffee Nasal and Toffee Nasal Pillows Mask in Home, USA, 2022

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