Investigative Headgear With CPAP Mask

Obstructive Sleep Apnea Clinical Trial

Official title:

Investigative Headgear With CPAP Mask

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323035
• Other study ID #: CIA150
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: November 2016

Study information

• Verified date: April 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 2-4 weeks.

Description:

Up to 300 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level PAP for the treatment of their OSA. These include current CPAP mask users.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• AHI=5 from the diagnostic night

• =18 years of age

• Prescribed CPAP or Bilevel therapy for OSA

• Existing CPAP mask users

Exclusion Criteria:

• Inability to give informed consent

• Patient intolerant to PAP

• Anatomical or physiological conditions making PAP therapy inappropriate

• History of respiratory disease or 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:
• Headgear
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	Participants perception of the headgear on mask performance	Assess if the headgear with mask changes the perception of the performance of the mask.	2-4 weeks
Secondary	Number of participants that choose this Headgear over their usual.	Assess the acceptability of the headgear with mask.	2-4 weeks