CPAP In-home Assessment Australia

NCT ID: NCT02809794

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-03-31

Brief Summary

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The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.

Detailed Description

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Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Investigational CPAP device

Fisher \& Paykel Healthcare CPAP Device

Group Type EXPERIMENTAL

Fisher & Paykel Healthcare CPAP Device

Intervention Type DEVICE

Fisher \& Paykel Healthcare CPAP Device

Interventions

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Fisher & Paykel Healthcare CPAP Device

Fisher \& Paykel Healthcare CPAP Device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Aged 18 and over.
* Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) therapy.

Exclusion Criteria

* Persons contraindicated for Continuous Positive Airway Pressure (CPAP) therapy.
* Persons with other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, central sleep apnea).
* Persons with obesity hypoventilation syndrome or congestive heart failure.
* Persons that require supplemental oxygen with their CPAP device.
* Persons with implanted electronic medical devices (e.g. cardiac pacemakers).
* Persons who are pregnant or think they might be pregnant.
* Persons whose primary language is other than English.
* Persons in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process.
* Persons highly dependent on medical care.
* People with cognitive impairment, an intellectual disability or a mental illness
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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Sleep Matters

Bulleen, Victoria, Australia

Site Status

Sleep & Snore Solutions

Bunbury, Western Australia, Australia

Site Status

St John of God Midland Public Hospital

Midland, Western Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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CIA175

Identifier Type: -

Identifier Source: org_study_id

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