NCT02741635

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4 years until next milestone

Results Posted

Study results publicly available

May 15, 2020

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

1 month

First QC Date

April 6, 2016

Results QC Date

May 4, 2020

Last Update Submit

August 19, 2024

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Participants Choose the Toffee Mask Based on First Impressions Over 3 Market Leading Masks

    12 hours

Secondary Outcomes (2)

  • Participants Consider the Toffee Mask to be as Comfortable, or Much More Comfortable Than Their Usual Mask

    12 hours

  • Participants Consider the Toffee Mask to be Easier or Much Easier to Fit and Adjust Than Their Current Mask

    12 hours

Study Arms (1)

New Nasal Pillows Mask

EXPERIMENTAL

Participants to use nasal pillows mask one night in lab overnight polysomnography.

Device: New Nasal Pillows Mask

Interventions

New Nasal Pillows MaskDEVICE

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

New Nasal Pillows Mask

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fisher & Paykel Healthcare Ltd

Auckland, East Tamaki, 2013, New Zealand

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Christine Lambert
Organization
Fisher & Paykel Healthcare Ltd.
christine.lambert@fphcare.co.nz
+64 9 574 0123

Study Officials

  • Bhavi Ogra, BSc

    Sponsor Employee

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2016

First Posted

April 18, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 19, 2024

Results First Posted

May 15, 2020

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

For product development purposes only. Data will be de-identified.

Locations

NZ(1)