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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Obstructive Sleep Apnea	Device: PMP-300E; Device: In-lab PSG	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	10 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	PMP-300E: Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.
Study Start Date :	June 2008
Actual Primary Completion Date :	May 2012
Actual Study Completion Date :	June 2012

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 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)	Device: PMP-300E; Data collected from Level 3 device; Other Names: SmartWatch; Portable Monitoring Device; Sleep Apnea; Home Study; Sleep Diagnostic Device Device: In-lab PSG; Data collected from Type I In-Lab Polysomnography; Other Name: Sleep Study

Outcome Measures

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Primary Outcome Measures :

1. AHI [ Time Frame: One night ]
   Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals.

Secondary Outcome Measures :

1. Apnea Index [ Time Frame: One night ]
   Number of events/hour of sleep
2. Hypopnea Index [ Time Frame: One night ]
   Number of events/hour of sleep. Hypopneas scored without EEG arousals.
3. Oxygen Saturation [ Time Frame: One night ]
   Mean oxygen saturation

Other Outcome Measures:

1. Attitude Toward Device Use Questionnaire Scores [ Time Frame: one night ]
   Questionnaire consisting of multiple questions, scored as 1 = disagree completely to 5 = agree completely, revealed the following mean scores

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
Center for Human Sleep Research
Redwood City, California, United States, 94063
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:	Clete A. Kushida M.D., Ph.D.	Stanford University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Clete A. Kushida, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier:	NCT01364740 History of Changes
Other Study ID Numbers:	SU-04212009-2358; K073327 ( Registry Identifier: clinicaltrials.stanford.edu ); SPO 42154 ( Other Identifier: Stanford University, OSR ); eProtocol 13181 ( Other Identifier: Stanford University, IRB )
First Posted:	June 2, 2011
Results First Posted:	January 27, 2017
Last Update Posted:	January 27, 2017
Last Verified:	December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes

Additional relevant MeSH terms:

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Respiration Disorders; Respiratory Tract Diseases	Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases