Investigative Headgear With CPAP Mask

Fisher and Paykel Healthcare23 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

HeadgearDEVICE

Investigative Headgear with CPAP Mask.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Fisher & Paykel Healthcare

Auckland, New Zealand

Outcomes

Primary Outcomes

Participants perception of the headgear on mask performance

Assess if the headgear with mask changes the perception of the performance of the mask.

Time frame: 2-4 weeks

Secondary Outcomes

Number of participants that choose this Headgear over their usual.

Assess the acceptability of the headgear with mask.

Time frame: 2-4 weeks

Data from ClinicalTrials.gov

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