Investigative Headgear With Nasal Pillows CPAP Mask

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

Sponsors

Lead sponsor: Fisher and Paykel Healthcare

Source 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.

Overall Status Completed
Start Date October 2016
Completion Date December 2017
Primary Completion Date December 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Reliability of the headgear using a Questionnaire Monthly over a period of 6 months
Durability of the headgear by testing Monthly over a period of 6 months
Secondary Outcome
Measure Time Frame
Performance in regards to leak of the headgear Monthly over a period of 6 months
Performance in regards to comfort of the headgear Monthly over a period of 6 months
Enrollment 20
Condition
Intervention

Intervention type: Device

Intervention name: Investigative Headgear with CPAP mask

Description: Investigative Headgear with CPAP mask

Arm group label: Headgear

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Sarah Gunson, BSc Principal Investigator Clinical Research Associate
Location
facility
Fisher & Paykel Healthcare
Location Countries

New Zealand

Verification Date

March 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Headgear

Arm group type: Experimental

Description: Investigative Headgear with CPAP mask

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov