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

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

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: PMP-300E; Device: In-lab PSG

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Sleep Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AHI	Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals.	One night

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea Index	Number of events/hour of sleep	One night
Hypopnea Index	Number of events/hour of sleep. Hypopneas scored without EEG arousals.	One night
Oxygen Saturation	Mean oxygen saturation	One night

Other Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (Estimate): June 2, 2011

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: December 2, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• 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)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes