N/A
Completed N=15
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Source: ClinicalTrials.gov NCT02741635 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Participants Choose the Toffee Mask Based on First Impressions Over 3 Market Leading Masks — 4 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Choose the Toffee Mask Based on First Impressions Over 3 Market Leading Masks |
4 | — |
| SECONDARY Participants Consider the Toffee Mask to be as Comfortable, or Much More Comfortable Than Their Usual Mask |
9 | — |
| SECONDARY Participants Consider the Toffee Mask to be Easier or Much Easier to Fit and Adjust Than Their Current Mask |
8 | — |
Eligibility Criteria
Inclusion Criteria
- Adult (18+ years of age)
- Able to give consent
- AHI ≥ 5 on diagnostic night
- Prescribed a CPAP device after successful OSA diagnosis
- Existing nasal pillows mask user
Exclusion Criteria
- Inability to give consent
- Patients who are in a coma or a decreased level of consciousness.
- Anatomical or physiological conditions making APAP therapy inappropriate
- Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
- Current diagnosis of CO2 retention
- Pregnant or may think they are pregnant.
Data sourced from ClinicalTrials.gov (NCT02741635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.