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

Study Overview
=================
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.

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

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: F&P Toffee Nasal and Toffee Nasal Pillows Masks


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F&P Toffee Nasal and Toffee Nasal Pillows Mask<br>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. | Device: F&P Toffee Nasal and Toffee Nasal Pillows Masks<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | After two weeks of use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | After two weeks of use | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Positive Airway Pressure Therapy