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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05496062
• Other study ID #: CIA-305
• Status: Completed
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: April 30, 2024
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• F&P Toffee Nasal and Toffee Nasal Pillows Masks
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.

Locations

Country	Name	City	State
United States	Clinical Site Partners, LLC - DBA CSP Miami	Miami	Florida
United States	Clayton Sleep Institute	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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