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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clete A. Kushida, Stanford University
ClinicalTrials.gov Identifier:
NCT01364740
First received: May 31, 2011
Last updated: December 2, 2016
Last verified: December 2016
  Purpose
Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.

Condition Intervention Phase
Obstructive Sleep Apnea Device: PMP-300E Device: In-lab PSG Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Clete A. Kushida, Stanford University:

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


Secondary Outcome Measures:
  • Apnea Index [ Time Frame: One night ]
    Number of events/hour of sleep

  • Hypopnea Index [ Time Frame: One night ]
    Number of events/hour of sleep. Hypopneas scored without EEG arousals.

  • Oxygen Saturation [ Time Frame: One night ]
    Mean oxygen saturation


Other Outcome Measures:
  • 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


Enrollment: 10
Study Start Date: June 2008
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364740

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

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 )
Study First Received: May 31, 2011
Results First Received: October 10, 2016
Last Updated: December 2, 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

ClinicalTrials.gov processed this record on August 18, 2017