CPAP In-home Assessment NZ

NCT ID: NCT02804919

Last Updated: 2018-08-03

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-06-16

Brief Summary

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Phase 1: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.

Phase 2: To evaluate the CPAP device with communication functionality with data upload.

Detailed Description

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Phase 1: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.

Phase 2: 10 participants from Phase 1 will be recruited to use the device for up to 6 month in-home. Participants will attend 3 study visits at day 0, 7 30. The trial may be extended to 60 days if longer term data is required.

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 Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
* Be fluent in spoken and written English

Exclusion Criteria

* Contraindicated for Positive Airway Pressure (CPAP or AutoCPAP) 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 Positive Airway Pressure (CPAP or AutoCPAP) device.
* Persons with implanted electronic medical devices (e.g cardiac pacemakers)
* Persons who are pregnant or think they may 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

Principal Investigators

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Irene Cheung, MSc/RPSGT

Role: PRINCIPAL_INVESTIGATOR

Fisher & Paykel Healthcare

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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CIA174

Identifier Type: -

Identifier Source: org_study_id

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