CPAP Device In-lab Assessment NZ

NCT ID: NCT02948010

Last Updated: 2017-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-03-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Auto CPAP + comfort feature A

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

Group Type ACTIVE_COMPARATOR

Auto CPAP + comfort feature A

Intervention Type DEVICE

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

Auto CPAP with comfort feature B

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

Group Type ACTIVE_COMPARATOR

Auto CPAP with comfort feature B

Intervention Type DEVICE

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

Auto CPAP with no comfort feature

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

Group Type ACTIVE_COMPARATOR

Auto CPAP with no comfort feature

Intervention Type DEVICE

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

Auto CPAP with comfort feature A+B

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

Group Type ACTIVE_COMPARATOR

Auto CPAP with comfort feature A+B

Intervention Type DEVICE

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

CPAP with comfort feature A

CPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device

Group Type ACTIVE_COMPARATOR

CPAP with comfort feature A

Intervention Type DEVICE

CPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device

CPAP with comfort feature B

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

Group Type ACTIVE_COMPARATOR

CPAP with comfort feature B

Intervention Type DEVICE

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

CPAP with no comfort feature

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

Group Type ACTIVE_COMPARATOR

CPAP with no comfort feature

Intervention Type DEVICE

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

CPAP with comfort feature A + B

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

Group Type ACTIVE_COMPARATOR

CPAP with comfort feature A + B

Intervention Type DEVICE

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

CPAP at Sub therapeutic level

CPAP at Sub therapeutic level using Fisher \& Paykel Healthcare CPAP Device

Group Type ACTIVE_COMPARATOR

CPAP at Sub therapeutic level

Intervention Type DEVICE

CPAP at Sub therapeutic level using Fisher \& Paykel Healthcare CPAP Device

Interventions

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Auto CPAP + comfort feature A

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

Intervention Type DEVICE

Auto CPAP with comfort feature B

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

Intervention Type DEVICE

Auto CPAP with no comfort feature

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

Intervention Type DEVICE

Auto CPAP with comfort feature A+B

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

Intervention Type DEVICE

CPAP with comfort feature A

CPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device

Intervention Type DEVICE

CPAP with comfort feature B

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

Intervention Type DEVICE

CPAP with no comfort feature

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

Intervention Type DEVICE

CPAP with comfort feature A + B

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

Intervention Type DEVICE

CPAP at Sub therapeutic level

CPAP at Sub therapeutic level using Fisher \& Paykel Healthcare CPAP Device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fisher & Paykel Healthcare

Auckland, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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CIA187

Identifier Type: -

Identifier Source: org_study_id

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