Text Size

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

This study is currently recruiting participants.
Verified July 2012 by Itamar-Medical, Israel
Sponsor:
Information provided by (Responsible Party):
Itamar-Medical, Israel
ClinicalTrials.gov Identifier:
NCT01570738
First received: March 28, 2012
Last updated: July 5, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Sleep Disorders

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Validation of Home Sleep Testing (WP200) Compared to an Overnight Sleep Testing in the Sleep Laboratory

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Itamar-Medical, Israel:

Primary Outcome Measures:
  • Compare sleep data collected from the Watch-PAT200 device to PSG data [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2012
  Eligibility

Ages Eligible for Study:   5 Years to 90 Years
Genders Eligible for Study:   Both
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

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570738

Locations
Israel
Carmel Medical Center Recruiting
Haifa, Israel
Contact: Giora Pillar         giorapi@clalit.org.il    
Principal Investigator: Giora Pillar, Prof.            
Sponsors and Collaborators
Itamar-Medical, Israel
  More Information

No publications provided

Responsible Party: Itamar-Medical, Israel
ClinicalTrials.gov Identifier: NCT01570738     History of Changes
Other Study ID Numbers: Carmel-001
Study First Received: March 28, 2012
Last Updated: July 5, 2012
Health Authority: Israel: Ethics Commission

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

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

ClinicalTrials.gov processed this record on May 19, 2013