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Completed

NCT Number: NCT01364740

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Center for Human Sleep Research, Redwood City, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PMP-300E

Device

Data collected from Level 3 device

Other names: SmartWatch, Portable Monitoring Device, Sleep Apnea, Home Study, Sleep Diagnostic Device

In-lab PSG

Device

Data collected from Type I In-Lab Polysomnography

Other names: Sleep Study

Primary outcomes

  1. AHI

    Time frame: One night

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

Secondary outcomes

  1. Apnea Index

    Time frame: One night

    Number of events/hour of sleep

  2. Hypopnea Index

    Time frame: One night

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

  3. Oxygen Saturation

    Time frame: One night

    Mean oxygen saturation

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: PMP-300E

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jun 2, 2011
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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