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

Phase 3

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: PMP-300E; Device: In-lab PSG

• Registration Number: NCT01364740
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-02
• Primary Completion: 2012-05
• Study Completion: 2012-06
• Results First Submitted: 2016-10-10
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-02
• Last Update Submitted: 2016-12-02
• Results First Posted: 2017-01-27
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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.

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Exclusion Criteria

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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PMP-300E, In-Lab PSG	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)
PMP-300E, In-Lab PSG	PMP-300E	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)

Primary Outcome Measures

Name	Time	Method
AHI	One night	Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals.

Secondary Outcome Measures

Name	Time	Method
Apnea Index	One night	Number of events/hour of sleep
Oxygen Saturation	One night	Mean oxygen saturation
Hypopnea Index	One night	Number of events/hour of sleep. Hypopneas scored without EEG arousals.

Trial Locations

Locations (2)

Center for Human Sleep Research; 🇺🇸 Redwood City, California, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States