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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05573763
• Other study ID #: CIA-308
• Status: Completed
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: June 16, 2023

Study information

• Verified date: September 2023
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 16, 2023
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• F&P Toffee
Nasal pillows mask

Locations

Country	Name	City	State
United States	Ohio Sleep Medicine Institute	Columbus	Ohio

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	Apnea-Hypopnea Index	Acceptable maintenance or lower (improved score) from baseline. Scores below 5 indicate a better outcome.	14±5 days
Primary	Epworth Sleepiness Scale	Acceptable maintenance or lower (improved score) from baseline. Scores below 11 indicate a better outcome.	14±5 days