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| ID | Type | Description | Link |
|---|---|---|---|
| K073327 | Registry Identifier | clinicaltrials.stanford.edu | |
| SPO 42154 | Other Identifier | Stanford University, OSR | |
| eProtocol 13181 | Other Identifier | Stanford University, IRB |
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Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PMP-300E, In-Lab PSG | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PMP-300E | Device | Data collected from Level 3 device |
|
| Measure | Description | Time Frame |
|---|---|---|
| AHI | Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals. | One night |
| 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. |
| 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 |
Inclusion Criteria:Inclusion Criteria:
Exclusion Criteria:Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clete A. Kushida M.D., Ph.D. | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Human Sleep Research | Redwood City | California | 94063 | United States | ||
| Stanford University School of Medicine |
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Patients were recruited through the patient population at the Stanford Sleep Medicine Center
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| ID | Title | Description |
|---|---|---|
| FG000 | SmartWatch PMP-300E | Investigational device Smart Watch PMP-300E to measure sleep-related breathing was tested against conventional gold-standard In-Lab Polysomnography (sleep studies) Smart Watch PMP-300E: Data collected from a Level 3 portable monitoring device In-lab Polysomnography: Data collected from Type I In-Lab Polysomnography |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PMP-300E, In-Lab PSG | 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) PMP-300E: Data collected from Level 3 device In-lab PSG: Data collected from Type I In-Lab Polysomnography |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AHI | Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals. | Posted | Mean | Standard Deviation | events/hour | One night |
|
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PMP-300E, In-Lab Polysomnography | Patient data from one night with the PMP-300E, compared to In-Lab PSG data |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clete A. Kushida, MD, PhD | Stanford University | 650-721-7560 | clete@stanford.edu |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017286 | Polysomnography |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| In-lab PSG | Device | Data collected from Type I In-Lab Polysomnography |
|
|
| One night |
| Oxygen Saturation | Mean oxygen saturation | One night |
| Stanford |
| California |
| 94305 |
| United States |
| years |
|
| Gender | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Epworth Sleepiness Scale score | Subjective measure of daytime sleepiness, 0-24 points, where higher numbers indicate greater levels of subjective daytime sleepiness | Mean | Standard Deviation | units on a scale |
|
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| Secondary | Apnea Index | Number of events/hour of sleep | Posted | Mean | Standard Deviation | events/hour | One night |
|
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|
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| Secondary | Hypopnea Index | Number of events/hour of sleep. Hypopneas scored without EEG arousals. | Posted | Mean | Standard Deviation | events/hour | One night |
|
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| Secondary | Oxygen Saturation | Mean oxygen saturation | Posted | Mean | Standard Deviation | percent | One night |
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| Other Pre-specified | 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 | Posted | Mean | Standard Deviation | units on a scale | one night |
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|
|
| 0 |
| 10 |
| 0 |
| 10 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Can read window display without difficulty |
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| Can hear the on/off beep without difficulty |
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| Can strap on chest belt without difficulty |
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| Importance of finding out more about own sleep |
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| Bed partner is a restless sleeper or loud snorer |
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