PMP-300E (Smart Watch): Portable Monitoring Device Study (PMP-300E)
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ClinicalTrials.gov Identifier: NCT01364740 |
Recruitment Status :
Completed
First Posted : June 2, 2011
Results First Posted : January 27, 2017
Last Update Posted : January 27, 2017
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Condition or disease | Intervention/treatment | Phase |
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Obstructive Sleep Apnea | Device: PMP-300E Device: In-lab PSG | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | N/A |
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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364740
United States, California | |
Center for Human Sleep Research | |
Redwood City, California, United States, 94063 | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Clete A. Kushida M.D., Ph.D. | Stanford University |
Responsible Party: | Clete A. Kushida, Principle Investigator, Stanford University |
ClinicalTrials.gov Identifier: | NCT01364740 |
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 Key Record Dates |
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 |
Sleep Apnea Syndromes Sleep Apnea, Obstructive Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |