Validation of Home Sleep Testing (WP200) Compared to an Overnight Sleep Testing in the Sleep Laboratory
| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 28, 2012 |
| Last Updated Date | July 5, 2012 |
| Start Date ICMJE | July 2012 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE |
Compare sleep data collected from the Watch-PAT200 device to PSG data [ Time Frame: 3 years ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01570738 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Validation of Home Sleep Testing (WP200) Compared to an Overnight Sleep Testing in the Sleep Laboratory |
| Official Title ICMJE | Validation of Home Sleep Testing (WP200) Compared to an Overnight Sleep Testing in the Sleep Laboratory |
| 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". |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| 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 |
| Condition ICMJE | Sleep Disorders |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Recruiting |
| Estimated Enrollment ICMJE | 150 |
| Completion Date | Not Provided |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 5 Years to 90 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Not Provided |
| Location Countries ICMJE | Israel |
| Administrative Information | |
| NCT Number ICMJE | NCT01570738 |
| Other Study ID Numbers ICMJE | Carmel-001 |
| Has Data Monitoring Committee | No |
| Responsible Party | Itamar-Medical, Israel |
| Study Sponsor ICMJE | Itamar-Medical, Israel |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Itamar-Medical, Israel |
| Verification Date | July 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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