Back to resultsPMP-300E (Smart Watch): Portable Monitoring Device Study (PMP-300E)
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PMP-300E
In-lab PSG
Sponsored by
About this trial
This is an interventional diagnostic trial for Obstructive Sleep Apnea
Eligibility 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.
Sites / Locations
- Center for Human Sleep Research
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PMP-300E, In-Lab PSG
Arm Description
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)
Outcomes
Primary Outcome Measures
AHI
Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals.
Secondary Outcome Measures
Apnea Index
Number of events/hour of sleep
Hypopnea Index
Number of events/hour of sleep. Hypopneas scored without EEG arousals.
Oxygen Saturation
Mean oxygen saturation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01364740
Brief Title
PMP-300E (Smart Watch): Portable Monitoring Device Study
Acronym
PMP-300E
Official Title
PMP-300E: Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PMP-300E, In-Lab PSG
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
PMP-300E
Other Intervention Name(s)
SmartWatch, Portable Monitoring Device, Sleep Apnea, Home Study, Sleep Diagnostic Device
Intervention Description
Data collected from Level 3 device
Intervention Type
Device
Intervention Name(s)
In-lab PSG
Other Intervention Name(s)
Sleep Study
Intervention Description
Data collected from Type I In-Lab Polysomnography
Primary Outcome Measure Information:
Title
AHI
Description
Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals.
Time Frame
One night
Secondary Outcome Measure Information:
Title
Apnea Index
Description
Number of events/hour of sleep
Time Frame
One night
Title
Hypopnea Index
Description
Number of events/hour of sleep. Hypopneas scored without EEG arousals.
Time Frame
One night
Title
Oxygen Saturation
Description
Mean oxygen saturation
Time Frame
One night
Other Pre-specified Outcome Measures:
Title
Attitude Toward Device Use Questionnaire Scores
Description
Questionnaire consisting of multiple questions, scored as 1 = disagree completely to 5 = agree completely, revealed the following mean scores
Time Frame
one night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clete A. Kushida M.D., Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Human Sleep Research
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
PMP-300E (Smart Watch): Portable Monitoring Device Study
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