CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
Toffee Nasal Pillows Maskdevice
Likely dose
Toffee nasal pillows mask used for 14 ± 5 daysAI-extracted
Key inclusion· 5
  • ✓Age ≥22 years
  • ✓AHI ≥5 on diagnostic sleep study
  • ✓Currently prescribed APAP, CPAP, or Bi-level PAP for OSA
  • ✓Existing nasal pillows mask user
Key exclusion· 4
  • ✕Intolerant to PAP therapy
  • ✕Anatomical or physiological conditions making PAP therapy inappropriate
  • ✕Current diagnosis of respiratory disease or CO2 retention
  • ✕Pregnant or suspected pregnancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03242148
NCT03242148N/ACompleted
CompareCT.gov

The Evaluation of the Toffee Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

Fisher and Paykel Healthcare·interventional·Posted Aug 8, 2017·Updated Sep 22, 2021

In Brief

A clinical study evaluating Toffee Nasal Pillows Mask for Obstructive Sleep Apnea. Completed, enrolled 38 participants across 1 site.

Detailed Summary

This investigation is a prospective, non-randomized, non-blinded study. This investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Toffee nasal pillows mask amongst obstructive sleep apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Ohio Sleep Medical Institute (OSMI)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea
CountriesUnited States
CollaboratorsAspen Clinical Research

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 8, 2017
Enrollment StartSep 16, 2017
Primary CompletionNov 3, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.9 years ago

Interventions

Toffee Nasal Pillows Maskdevice

Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.