CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
New Nasal Pillows Maskdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02741635
NCT02741635N/ACompleted

The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ

Fisher and Paykel Healthcare·interventional·Posted Apr 18, 2016·Updated Sep 19, 2024

In Brief

A clinical study evaluating New Nasal Pillows Mask for Obstructive Sleep Apnea. Completed, enrolled 15 participants across 1 site.

Detailed Summary

This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants. Also to assist in the development process it would be beneficial to get feedback from users on certain aspects of the design. The aim of this investigation is to get feedback on the first impressions (look and feel) from users of nasal pillows PAP therapy. A total number of 15 participants who currently use a nasal pillows mask will be recruited for the trial. Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher \& Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI). Participants will undergo an overnight polysomnography session at the Fisher \& Paykel Healthcare sleep lab. The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the overnight in-lab study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNew Zealand
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 18, 2016
Enrollment StartApr 1, 2016
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 10.2 years ago

Interventions

New Nasal Pillows Maskdevice

Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)