PMP-300E (Smart Watch): Portable Monitoring Device Study

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

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-06-30

Brief Summary

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Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.

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Detailed Description

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The purpose of the study is to validate an Obstructive Sleep Apnea portable monitoring device, PMP-300E. Validating process compared data collected by PMP-300E with data collected from in-lab polysomnography.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PMP-300E, In-Lab PSG

PMP-300E, A 7-channel (nasal pressure, effort, snoring, SpO2, pulse rate, body position and movement) Level 3 portable monitor (11.2 x 3.3 x 5.5cm, 80g, Pacific Medico Co., LTD) to measure sleep-related breathing will be tested against conventional gold-standard In-Lab Polysomnography (sleep study)

Group Type EXPERIMENTAL

PMP-300E

Intervention Type DEVICE

Data collected from Level 3 device

In-lab PSG

Intervention Type DEVICE

Data collected from Type I In-Lab Polysomnography

Interventions

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PMP-300E

Data collected from Level 3 device

Intervention Type DEVICE

In-lab PSG

Data collected from Type I In-Lab Polysomnography

Intervention Type DEVICE

Other Intervention Names

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SmartWatch Portable Monitoring Device Sleep Apnea Home Study Sleep Diagnostic Device Sleep Study

Eligibility Criteria

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Inclusion Criteria

* Age 18 and over.
* Require a sleep diagnostic study by physician's order.
* Able and willing to provide written informed consent.
* Able to speak and read English.

Exclusion Criteria

* Participation in another interventional research study within the last 30 days.
* Unstable medical or psychiatric conditions that would interfere with the demands of the study or the ability to commit to follow-up assessment. Examples include unstable congestive heart failure, neuromuscular disease, cancer, and renal failure.
* Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (\> 45 mmHg) while awake or participants qualifying for oxygen therapy (arterial saturation 88% for more than five minutes).
* Consumption of ethanol more than 4 nights per week. (CAGE criteria)
* Use of recreational drug within the past 12 months.
* Women who are pregnant or currently lactating.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No