Investigative Headgear With Nasal Pillows Continuous Positive Airway Pressure (CPAP) Mask

Investigative Headgear With Nasal Pillows CPAP Mask

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02942446

Enrollment

Registered

2016-10-24

Start date

2016-10-31

Completion date

2017-12-31

Last updated

2019-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Brief summary

This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.

Detailed description

20 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level Positive airway pressure (PAP) for the treatment of their Obstructive Sleep Apnea (OSA). These include current CPAP mask users.

Interventions

DEVICEInvestigative Headgear with CPAP mask

Investigative Headgear with CPAP mask

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* AHI≥5 from the diagnostic night * ≥18 years of age * Prescribed CPAP or Bi-level therapy for OSA * Existing F&P Pilairo Q, Eson, Simplus mask users

Exclusion criteria

* Inability to give informed consent * Patient intolerant to CPAP * Anatomical or physiological conditions making CPAP therapy inappropriate * History of respiratory disease or carbon dioxide (CO2) retention * Pregnant or think they may be pregnant * Investigated by Land Transport Safety Authority

Design outcomes

Primary

Measure	Time frame	Description
Reliability of the headgear using a Questionnaire	Monthly over a period of 6 months	Assessment of headgear properties on a monthly basis via custom questionnaire via phone call
Durability of the headgear by testing	Monthly over a period of 6 months	Assessment of headgear properties on a monthly basis, and changes to the headgear

Secondary

Measure	Time frame	Description
Performance in regards to leak of the headgear	Monthly over a period of 6 months	Objective Leak Data (L/min) from the device download
Performance in regards to comfort of the headgear	Monthly over a period of 6 months	Custom Questionnaire

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026