NCT01364740

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2008

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

January 27, 2017

Completed
Last Updated

January 27, 2017

Status Verified

December 1, 2016

Enrollment Period

3.9 years

First QC Date

May 31, 2011

Results QC Date

October 10, 2016

Last Update Submit

December 2, 2016

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • AHI

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

    One night

Secondary Outcomes (3)

  • Apnea Index

    One night

  • Hypopnea Index

    One night

  • Oxygen Saturation

    One night

Other Outcomes (1)

  • Attitude Toward Device Use Questionnaire Scores

    one night

Study Arms (1)

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)

Device: PMP-300EDevice: In-lab PSG

Interventions

PMP-300EDEVICE

Data collected from Level 3 device

Also known as: SmartWatch, Portable Monitoring Device, Sleep Apnea, Home Study, Sleep Diagnostic Device
PMP-300E, In-Lab PSG
In-lab PSGDEVICE

Data collected from Type I In-Lab Polysomnography

Also known as: Sleep Study
PMP-300E, In-Lab PSG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Human Sleep Research

Redwood City, California, 94063, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Clete A. Kushida, MD, PhD
Organization
Stanford University
clete@stanford.edu
650-721-7560

Study Officials

  • Clete A. Kushida M.D., Ph.D.

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 2, 2011

Study Start

June 1, 2008

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

January 27, 2017

Results First Posted

January 27, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will share

Locations

US(2)