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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Investigative Headgear with CPAP mask
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fisher & Paykel Healthcare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Headgear

Arm Description

Investigative Headgear with CPAP mask

Outcomes

Primary Outcome Measures

Reliability of the headgear using a Questionnaire
Assessment of headgear properties on a monthly basis via custom questionnaire via phone call
Durability of the headgear by testing
Assessment of headgear properties on a monthly basis, and changes to the headgear

Secondary Outcome Measures

Performance in regards to leak of the headgear
Objective Leak Data (L/min) from the device download
Performance in regards to comfort of the headgear
Custom Questionnaire

Full Information

First Posted
October 11, 2016
Last Updated
March 19, 2019
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02942446
Brief Title
Investigative Headgear With Nasal Pillows Continuous Positive Airway Pressure (CPAP) Mask
Official Title
Investigative Headgear With Nasal Pillows CPAP Mask
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Headgear
Arm Type
Experimental
Arm Description
Investigative Headgear with CPAP mask
Intervention Type
Device
Intervention Name(s)
Investigative Headgear with CPAP mask
Intervention Description
Investigative Headgear with CPAP mask
Primary Outcome Measure Information:
Title
Reliability of the headgear using a Questionnaire
Description
Assessment of headgear properties on a monthly basis via custom questionnaire via phone call
Time Frame
Monthly over a period of 6 months
Title
Durability of the headgear by testing
Description
Assessment of headgear properties on a monthly basis, and changes to the headgear
Time Frame
Monthly over a period of 6 months
Secondary Outcome Measure Information:
Title
Performance in regards to leak of the headgear
Description
Objective Leak Data (L/min) from the device download
Time Frame
Monthly over a period of 6 months
Title
Performance in regards to comfort of the headgear
Description
Custom Questionnaire
Time Frame
Monthly over a period of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Gunson, BSc
Organizational Affiliation
Clinical Research Associate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fisher & Paykel Healthcare
City
Auckland
ZIP/Postal Code
2013
Country
New Zealand

12. IPD Sharing Statement

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

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