F&P Toffee Nasal and Toffee Nasal Pillows Masks for Obstructive Sleep Apnea (OSA)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Clinical Site Partners, LLC - DBA CSP Miami, Miami, FL
Obstructive Sleep Apnea (OSA)+1 More
F&P Toffee Nasal and Toffee Nasal Pillows Masks - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Obstructive Sleep Apnea (OSA)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Obstructive Sleep Apnea (OSA)

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: After two weeks of use

After two weeks of use
Comfort
Therapeutic Efficacy

Trial Safety

Safety Progress

1 of 3

Other trials for Obstructive Sleep Apnea (OSA)

Trial Design

1 Treatment Group

F&P Toffee Nasal and Toffee Nasal Pillows Mask
1 of 1
Experimental Treatment

90 Total Participants · 1 Treatment Group

Primary Treatment: F&P Toffee Nasal and Toffee Nasal Pillows Masks · No Placebo Group · N/A

F&P Toffee Nasal and Toffee Nasal Pillows Mask
Device
Experimental Group · 1 Intervention: F&P Toffee Nasal and Toffee Nasal Pillows Masks · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: after two weeks of use
Closest Location: Clinical Site Partners, LLC - DBA CSP Miami · Miami, FL
Photo of Miami 1Photo of Miami 2Photo of Miami 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Obstructive Sleep Apnea (OSA)
0 CompletedClinical Trials

Who is running the clinical trial?

Fisher and Paykel HealthcareLead Sponsor
108 Previous Clinical Trials
8,489 Total Patients Enrolled
50 Trials studying Obstructive Sleep Apnea (OSA)
2,037 Patients Enrolled for Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are ≥ 22 years of age.
You are ≥ 66 lbs (30 kgs).
You have an IPAP pressure of < 20 cmH2O.
You are currently using a PAP therapy device with data recording capabilities.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.