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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Investigative Headgear with CPAP mask

• Registration Number: NCT02942446
• Lead Sponsor: Fisher and Paykel Healthcare

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-20
• Study First Posted: 2016-10-24
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Headgear	Investigative Headgear with CPAP mask	Investigative Headgear with CPAP mask

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fisher & Paykel Healthcare; 🇳🇿 Auckland, New Zealand