Validation of Home Sleep Testing (WP200) Compared to an Overnight Sleep Testing in the Sleep Laboratory

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Itamar-Medical, Israel
Sponsor:
Information provided by (Responsible Party):
Itamar-Medical, Israel
ClinicalTrials.gov Identifier:
NCT01570738
First received: March 28, 2012
Last updated: April 22, 2014
Last verified: April 2014

March 28, 2012
April 22, 2014
July 2012
July 2016   (final data collection date for primary outcome measure)
Compare sleep data collected from the Watch-PAT200 device to PSG data [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01570738 on ClinicalTrials.gov Archive Site
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Validation of Home Sleep Testing (WP200) Compared to an Overnight Sleep Testing in the Sleep Laboratory
Validation of Home Sleep Testing (WP200) Compared to an Overnight Sleep Testing in the Sleep Laboratory

Obstructive sleep apnea syndrome (OSAS) is considered to be a major public health problem. The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated. The prevalence of snoring in children is high - 5% in the age group of 6 and less and about 1.5% above. The in-lab sleep study using full Polysomnography (PSG) and the manual scoring criteria set by the American Academy of Sleep Medicine was considered the gold standard for OSAS diagnosis. The high cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led to the commonly used procedure of "split-night" for OSAS patients, as well as to the development of a variety of ambulatory sleep study systems. The primary study objective is to compare the efficacy of the WatchPAT200 (WP200), as an ambulatory device for aiding in the diagnosis of sleep disorders for subjects from age 5 to 90, to the manual scoring of the PSG that serves as a "gold standard".

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Observational
Time Perspective: Prospective
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Non-Probability Sample

Adults and children with and without sleep disorders, referred to Carmel Medical Center clinical sleep laboratory for an overnight sleep study

Sleep Disorders
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
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July 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age between 5-90
  2. Subjects that are able to read understand and sign the informed consent form to undergo an overnight sleep study in the clinical sleep laboratory

Exclusion Criteria:

  1. Permanent pacemaker.
  2. Severe lung disease.
  3. Peripheral neuropathy.
  4. Finger deformity that precludes adequate sensor appliance.
  5. 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).
Both
5 Years to 90 Years
Yes
Israel
 
NCT01570738
Carmel-001
No
Itamar-Medical, Israel
Itamar-Medical, Israel
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Itamar-Medical, Israel
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP