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

NCT02741635 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-09-19

Study results available
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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.

Conditions

Interventions

DEVICE

New Nasal Pillows Mask

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

Sponsors & Collaborators

  • Fisher and Paykel Healthcare

    lead INDUSTRY

Principal Investigators

  • Bhavi Ogra, BSc · Sponsor Employee

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02741635 on ClinicalTrials.gov