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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02741635
• Other study ID #: CIA-190
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: May 2016

Study information

• Verified date: May 2020
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• New Nasal Pillows Mask
Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)

Locations

Country	Name	City	State
New Zealand	Fisher & Paykel Healthcare Ltd	Auckland	East Tamaki

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First Initial Impressions of the Toffee Nasal Pillows Mask Assessed Using a Custom Questionnaire	Participants choose the Toffee mask based on first impressions over 3 market leading masks.	12 hours
Secondary	Comfort of the Toffee Nasal Pillows Mask Assessed Using a Custom Questionnaire	Participants consider the Toffee mask to be as comfortable, or much more comfortable than their usual mask.	12 hours
Secondary	Usability of the Toffee Nasal Pillows Mask Assessed With Visual Observations	Participants consider the Toffee mask to be easier or much easier to fit and adjust than their current mask	12 hours