Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01364740
First received: May 31, 2011
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Sleep Apnea Syndromes
 Device: Smart Watch PMP-300E
Device: SmartWatch PMP-300E
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • AHI [ Time Frame: Max. 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change of the above variables between PMP-300E data collect at Visit 2 (at home) and Visit 4 (in-lab) [ Time Frame: Max. 14 days ] [ Designated as safety issue: No ]
Enrollment: 11
Study Start Date: April 2008
Study Completion Date: June 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SmartWatch PMP-300E Device: Smart Watch PMP-300E
Compare data collected from PMP-300E (SmartWatch) Type III portable monitoring device to Type II in-lab polysomnography data.
Other Names:
  • SmartWatch
  • Portable Monitoring Device
  • Sleep Apnea
  • Home Study
  • Sleep Diagnostic Device
Device: SmartWatch PMP-300E
Compare data collected from PMP-300E (SmartWatch) portable monitoring device to In-Lab monitored polysomnography data.
Other Names:
  • SmartWatch
  • Sleep Diagnostic Device
  • Portable Monitoring Device
  • Home Monitoring Device
  • Sleep Apnea
  • Type III Diagnostic Study

Detailed Description:

The purpose of the study is to validate an Obstructive Sleep Apnea portable monitoring device, PMP-300E. Validating process will be done by comparing data collected by PMP-300E with data collected from in-lab sleep diagnostic system, Alice4.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01364740     History of Changes
Other Study ID Numbers: SU-04212009-2358, K073327, SPO 42154, eProtocol 13181
Study First Received: May 31, 2011
Last Updated: November 28, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Apnea
Dyssomnias
Nervous System Diseases
 Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on February 25, 2015