CPAP Device In-lab Assessment NZ

Fisher and Paykel Healthcare104 enrolled

Overview

The purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements

Existing Adult Continuous Positive Airway Pressure (CPAP) therapy users will be recruited for an overnight polysomnography (PSG) sleep study. The participants will use the investigational CPAP device and be connected to a PSG during their session. The device performance during the session will be assessed. Outcomes of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires and PSG data.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

104

Conditions

Obstructive Sleep Apnea

Interventions

Auto CPAP + comfort feature ADEVICE

Auto CPAP + comfort feature A using Fisher \& Paykel Healthcare CPAP Device

Auto CPAP with comfort feature BDEVICE

Auto CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device

Auto CPAP with no comfort featureDEVICE

Auto CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years or older * Diagnosed with OSA by a practicing physician and prescribed PAP therapy (fixed or auto CPAP) * Fluent in spoken and written English. Exclusion Criteria: * Be contraindicated for PAP (fixed or auto CPAP) therapy. * Have another significant sleep disorder(s) (e.g. periodic leg movements or insomnia). * Have obesity hypoventilation syndrome or congestive heart failure. * Require supplemental oxygen with your PAP (fixed or auto CPAP) device. * Have any implanted electronic medical devices (e.g. cardiac pacemakers). * Be pregnant or think they might be pregnant.

Locations (1)

Fisher & Paykel Healthcare

Auckland, New Zealand

Outcomes

Primary Outcomes

Apnea Hypopnea Index (AHI) (i.e. number of events/hour).

Obtained from device and PSG data

Time frame: 4 months

Log of safety-related events, measured as number of safety-related faults

Obtained from device

Time frame: 4 months

Machine reported faults, measured as number of machine faults

Obtained from device

Time frame: 4 months

Secondary Outcomes

Participant perception of the device, as determined by the questionnaire responses

Obtained through user questionnaire

Time frame: 4 months

Data from ClinicalTrials.gov

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