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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01364740
Acronym
PMP-300E
Enrollment
10
Registered
2011-06-02
Start date
2008-06-30
Completion date
2012-06-30
Last updated
2017-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

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.

Interventions

DEVICEPMP-300E

Data collected from Level 3 device

DEVICEIn-lab PSG

Data collected from Type I In-Lab Polysomnography

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
AHIOne nightApnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals.

Secondary

MeasureTime frameDescription
Apnea IndexOne nightNumber of events/hour of sleep
Hypopnea IndexOne nightNumber of events/hour of sleep. Hypopneas scored without EEG arousals.
Oxygen SaturationOne nightMean oxygen saturation

Other

MeasureTime frameDescription
Attitude Toward Device Use Questionnaire Scoresone nightQuestionnaire consisting of multiple questions, scored as 1 = disagree completely to 5 = agree completely, revealed the following mean scores

Countries

United States

Participant flow

Recruitment details

Patients were recruited through the patient population at the Stanford Sleep Medicine Center

Participants by arm

ArmCount
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
10
Total10

Baseline characteristics

CharacteristicPMP-300E, In-Lab PSG
Age, Customized
Men
54.3 years
STANDARD_DEVIATION 15.46
Age, Customized
Women
56.8 years
STANDARD_DEVIATION 14.24
Body Mass Index
Men
29.5 kg/m^2
STANDARD_DEVIATION 9.54
Body Mass Index
Women
30.8 kg/m^2
STANDARD_DEVIATION 11.76
Epworth Sleepiness Scale score6.9 units on a scale
STANDARD_DEVIATION 5.61
Gender
Female
4 Participants
Gender
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

AHI

Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals.

Time frame: One night

ArmMeasureGroupValue (MEAN)Dispersion
PMP-300E, In-Lab PolysomnographyAHIPMP-300E19.2 events/hourStandard Deviation 14.5
PMP-300E, In-Lab PolysomnographyAHIIn-Lab PSG19.3 events/hourStandard Deviation 14.5
Comparison: Patient data from one night with the PMP-300E compared to In-Lab PSG datap-value: >0.05Sign test
Secondary

Apnea Index

Number of events/hour of sleep

Time frame: One night

ArmMeasureGroupValue (MEAN)Dispersion
PMP-300E, In-Lab PolysomnographyApnea IndexPMP-300E7.7 events/hourStandard Deviation 11.06
PMP-300E, In-Lab PolysomnographyApnea IndexIn-Lab PSG9.8 events/hourStandard Deviation 13.32
Comparison: Patient data from one night with the PMP-300E compared to In-Lab PSG datap-value: >0.05Sign test
Secondary

Hypopnea Index

Number of events/hour of sleep. Hypopneas scored without EEG arousals.

Time frame: One night

ArmMeasureGroupValue (MEAN)Dispersion
PMP-300E, In-Lab PolysomnographyHypopnea IndexPMP-300E8.8 events/hourStandard Deviation 4.96
PMP-300E, In-Lab PolysomnographyHypopnea IndexIn-Lab PSG14.1 events/hourStandard Deviation 19
Comparison: Patient data from one night with the PMP-300E compared to In-Lab PSG datap-value: >0.05Sign test
Secondary

Oxygen Saturation

Mean oxygen saturation

Time frame: One night

ArmMeasureGroupValue (MEAN)Dispersion
PMP-300E, In-Lab PolysomnographyOxygen SaturationPMP-300E94.8 percentStandard Deviation 2.1
PMP-300E, In-Lab PolysomnographyOxygen SaturationIn-Lab PSG95.0 percentStandard Deviation 2.11
Comparison: Patient data from one night with the PMP-300E compared to In-Lab PSG datap-value: >0.05Sign test
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

Time frame: one night

ArmMeasureGroupValue (MEAN)Dispersion
PMP-300E, In-Lab PolysomnographyAttitude Toward Device Use Questionnaire ScoresConfident in using device at home4.3 units on a scaleStandard Deviation 0.82
PMP-300E, In-Lab PolysomnographyAttitude Toward Device Use Questionnaire ScoresConfident in applying nasal cannula on own4.4 units on a scaleStandard Deviation 0.84
PMP-300E, In-Lab PolysomnographyAttitude Toward Device Use Questionnaire Scoresconfident in applying finger probe on own4.9 units on a scaleStandard Deviation 0.32
PMP-300E, In-Lab PolysomnographyAttitude Toward Device Use Questionnaire ScoresCan read window display without difficulty3.9 units on a scaleStandard Deviation 0.99
PMP-300E, In-Lab PolysomnographyAttitude Toward Device Use Questionnaire ScoresCan hear the on/off beep without difficulty3.8 units on a scaleStandard Deviation 1.03
PMP-300E, In-Lab PolysomnographyAttitude Toward Device Use Questionnaire ScoresCan strap on chest belt without difficulty4.5 units on a scaleStandard Deviation 0.71
PMP-300E, In-Lab PolysomnographyAttitude Toward Device Use Questionnaire ScoresImportance of finding out more about own sleep4.8 units on a scaleStandard Deviation 0.42
PMP-300E, In-Lab PolysomnographyAttitude Toward Device Use Questionnaire ScoresBed partner is a restless sleeper or loud snorer1.2 units on a scaleStandard Deviation 1.4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026