CPAP In-home Assessment USA

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-04-30

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.

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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 22 and over
* Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
* For experienced users of PAP (CPAP or AutoCPAP) - you must be using PAP of more than 4 hours/night for 70% during the last 30 days.

Exclusion Criteria

* Contraindicated for PAP (CPAP or AutoCPAP) therapy
* Has other significant sleep disorders (e.g periodic leg movements, insomnia, central sleep apnea)
* Has obesity hypoventilation syndrome or congestive heart failure
* Requires supplemental oxygen with their PAP (CPAP or AutoCPAP) device
* Has implanted electronic medical devices (e.g cardiac pacemakers)
* Pregnant or think they may be pregnant
* Not fluent in spoken and written English.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No