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PMP-300E (Smart Watch): Portable Monitoring Device Study (PMP-300E)
This study has been completed.
Sponsor:
Stanford University
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
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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:
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01364740
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