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N/A

F&P Toffee mask for Obstructive Sleep Apnea

N/A
Waitlist Available
Research Sponsored by Fisher and Paykel Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 ± 5 days in-home
Awards & highlights
No Placebo-Only Group

Summary

This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.

Eligible Conditions
  • Obstructive Sleep Apnea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 ± 5 days in-home
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 ± 5 days in-home for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Trial Mask Comfort
Trial Mask Ease-of-Use
Trial Mask Performance - Objective
+2 more
Secondary study objectives
Efficacy Data
Mask Leak Data
Seal Size Determination

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: F&P Toffee maskExperimental Treatment1 Intervention
Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
F&P Toffee mask
2017
N/A
~40

Find a Location

Who is running the clinical trial?

Fisher and Paykel HealthcareLead Sponsor
120 Previous Clinical Trials
9,740 Total Patients Enrolled
~5 spots leftby Oct 2025
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