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WatchPAT Device Validation Study Compared to Polysomnography

NCT03188718 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-04-21

Study results available
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Summary

Validation study of a novel sleep Device compared to a traditional sleep study.

Conditions

  • Sleep Apnea Syndromes
  • Sleep Disorder
  • Sleep

Interventions

DEVICE

WatchPAT Intervention

Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.

Sponsors & Collaborators

  • Kaiser Permanente

    collaborator OTHER

  • Itamar-Medical, Israel

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Michelle Sobremonte-King, MD · University of Colorado, Denver

  • Ann Halbower, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-07
Primary Completion
2019-06-01
Completion
2019-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03188718 on ClinicalTrials.gov