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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01570738
Recruitment Status : Recruiting
First Posted : April 4, 2012
Last Update Posted : March 6, 2018
Information provided by (Responsible Party):
Itamar-Medical, Israel

Brief Summary:
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".

Condition or disease
Sleep Disorders

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Validation of Home Sleep Testing (WP200) Compared to an Overnight Sleep Testing in the Sleep Laboratory
Study Start Date : July 2012
Estimated Primary Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Primary Outcome Measures :
  1. Compare sleep data collected from the Watch-PAT200 device to PSG data [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults and children with and without sleep disorders, referred to Carmel Medical Center clinical sleep laboratory for an overnight sleep study

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01570738

Carmel Medical Center Recruiting
Haifa, Israel
Contact: Giora Pillar   
Principal Investigator: Giora Pillar, Prof.         
Sponsors and Collaborators
Itamar-Medical, Israel

Responsible Party: Itamar-Medical, Israel Identifier: NCT01570738     History of Changes
Other Study ID Numbers: Carmel-001
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

Keywords provided by Itamar-Medical, Israel:
sleep disorders
sleep apnea
ambulatory device

Additional relevant MeSH terms:
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders