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WithdrawnNCT02378831Updated Aug 27, 2015

Comparison of In-lab PSG to WP200 for Assessing Sleep Parameters

An observational study in Sleep, sponsored by Itamar-Medical, Israel. Withdrawn. Open to participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-27.

Sponsored by Itamar-Medical, Israel · Observational

Why this study was withdrawn
has not begun yet.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Ages
12 Years to 17 Years
Sex
All
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Study 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.

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Conditions studied

  • Sleep

Keywords

  • diagnosing sleep
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In context

Lead sponsor

Itamar-Medical, Israel is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • PSG and WatchPAT200 in subjects age12-17

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

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What researchers measure

Primary outcomes

  1. 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"

    Time frame: 1 night

  2. 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"

    Time frame: 1 night

  3. 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"

    Time frame: 1 night

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02378831
Lead sponsor
Itamar-Medical, Israel
Responsible party
Sponsor
First posted
Mar 4, 2015
Start date
Mar 2016
Primary completion
Jul 2016 (estimated)
Last update
Aug 27, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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