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CompletedNCT01929447Updated Sep 19, 2014

Evaluation of WP200 With the Unified Probe (WP200U)

An observational study in Sleep Disorders, sponsored by Itamar-Medical, Israel. Completed at 1 site in Israel. Open to participants aged 5 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-19.

Sponsored by Itamar-Medical, Israel · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
75
Ages
5 Years to 90 Years
Sex
All
01

Study summary

The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated. The severity of the disorder is expressed by the Apnea Hypopnea Index (AHI) which is the number of Apnea/Hypopnea episodes per hours of actual sleep and the Respiratory Disturbances Index (RDI) which is an extended index incorporating in addition to the previous episodes also respiratory effort related arousal episodes. The high cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led to the development of a variety of ambulatory sleep study systems.

The primary objective of the study is to evaluate the newly developed WP200 with the unified probe (WP200U) compared to the currently used configuration of WP200 that uses an incorporated Nonin oximetry module in the sleep lab or in the home sleep environment.

02

Conditions studied

  • Sleep Disorders

Keywords

  • sleep disorders
  • sleep apnea
  • ambulatory device
  • WatchPAT
03

In context

Sleep Wake Disorders

788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.

This study's enrollment of 75 is below the median of 114 across 215 observational studies indexed under Sleep Wake Disorders.

Browse Sleep Wake Disorders studies →

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.

04

Who can participate

Ages eligible
5 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects, adults and children, with suspected sleep disorders who are referred to a sleep study and are willing to participate in this clinical study.

Additional non selective volunteers who are willing to participate in this clinical study and consent to undergo an overnight sleep study at their home.

Inclusion criteria

  • Age between 5-90
  • Subjects that are able to read understand and sign the informed consent form of the study or by parents of subjects that are less than 18 years of age that are either referred or volunteering to undergo an overnight sleep study in the clinical sleep laboratory or at home

Exclusion criteria

Exclusion Criteria:

  • Permanent pacemaker.
  • Severe lung disease.
  • Severe peripheral neuropathy.
  • Finger deformity that precludes adequate sensor appliance.
  • Using one of the following medications: short/Long acting nitrates (less than 3 hours before the sleep study) or alpha-adrenergic receptor blockers (less than 24 hours before the sleep study).
05

Study design

Time perspective
Prospective
Enrollment
75 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Sleep respiratory parameters

    pRDI, pAHI, ODI

    Time frame: 3 years

07

Study locations

1 site
  • Carmel Medical Center
    Haifa, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2014, 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
NCT01929447
Lead sponsor
Itamar-Medical, Israel
Responsible party
Sponsor
First posted
Aug 28, 2013
Start date
Oct 2013
Primary completion
Sep 2014
Last update
Sep 19, 2014

Oversight

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

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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