Investigative Headgear With CPAP Mask

Fisher & Paykel Healthcare

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Headgear

Study type: Interventional

Funder types: Industry

Identifiers

NCT02323035

CIA150

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Headgear

Experimental group

Description:

Investigative Headgear with CPAP Mask.

Treatment:

Device: Headgear