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

Obstructive Sleep Apnea Clinical Trial

Official title:

Investigative Headgear With Nasal Pillows CPAP Mask

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02942446
• Other study ID #: CIA 150
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 2017

Study information

• Verified date: March 2019
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• Investigative Headgear with CPAP mask
Investigative Headgear with CPAP mask

Locations

Country	Name	City	State
New Zealand	Fisher & Paykel Healthcare	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability of the headgear using a Questionnaire	Assessment of headgear properties on a monthly basis via custom questionnaire via phone call	Monthly over a period of 6 months
Primary	Durability of the headgear by testing	Assessment of headgear properties on a monthly basis, and changes to the headgear	Monthly over a period of 6 months
Secondary	Performance in regards to leak of the headgear	Objective Leak Data (L/min) from the device download	Monthly over a period of 6 months
Secondary	Performance in regards to comfort of the headgear	Custom Questionnaire	Monthly over a period of 6 months