NCT02378831

Brief Summary

The WP200 and/or WP200U will be compared with a PSG system which is a digital physiological recorder system, cleared for use for clinical sleep studies. The manual scoring of the PSG data, performed by a trained and authorized scorer, according to the AASM (American Academy of Sleep Medicine) guidelines, serves as a "gold standard" for all determinations of efficacy.

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
12 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

August 27, 2015

Status Verified

February 1, 2015

Enrollment Period

4 months

First QC Date

February 17, 2015

Last Update Submit

August 25, 2015

Conditions

Sleep

Keywords

diagnosing sleep

Outcome Measures

Primary Outcomes (3)

  • sensitivity, specificity, obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"

    1 night

  • correlation obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"

    1 night

  • Agreement obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"

    1 night

Study Arms (1)

PSG and WatchPAT200 in subjects age12-17

Adolescents refered to a sleep lab for sleep lab for full night PSG

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The study population will include adolescence subjects, age 12-17, referred to the clinical sleep laboratory for an overnight sleep study

You may qualify if:

  • Age between 12-17
  • Subjects with a legal guardian that is able to read understand and sign the informed consent form
  • Willing to sleep with the WP200/WP200U and PSG simultaneously in the sleep lab

You may not qualify if:

  • Permanent pacemaker: atrial pacing or VVI without sinus rhythm.
  • Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2015

First Posted

March 4, 2015

Study Start

March 1, 2016

Primary Completion

July 1, 2016

Last Updated

August 27, 2015

Record last verified: 2015-02