Validation of Portable Monitoring Device for Diagnosing Sleep Apnea
This study has been completed.
Sponsor:
Chinese University of Hong Kong
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00628511
First received: February 6, 2008
Last updated: February 25, 2008
Last verified: February 2008
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 6, 2008 | ||||
| Last Updated Date | February 25, 2008 | ||||
| Start Date ICMJE | January 2007 | ||||
| Estimated Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
validity of portable monitoring device [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00628511 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 Portable Monitoring Device for Diagnosing Sleep Apnea | ||||
| Official Title ICMJE | A Validation Study of A New Diagnostic Device for Screening of Obstructive Sleep Apnea in High Risk Patient Population | ||||
| Brief Summary | portable monitoring device could diagnose sleep apnea in high risk patients. |
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| Detailed Description | This is a pilot study of another larger cohort investigating different algorithms in managing patients suspected of sleep apnea using portable monitoring device. Portable monitoring device is applied simultaneously with PSG to compare it's accuracy and validity. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | patients suspected of sleep apnea |
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| Condition ICMJE | Sleep Apnea | ||||
| Intervention ICMJE | Device: ARES (Apnea Risk Evaluation System)
application of portable monitoring device with PSG |
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| Study Group/Cohort (s) | observation
Intervention: Device: ARES (Apnea Risk Evaluation System) |
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| 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 | Completed | ||||
| Enrollment ICMJE | 175 | ||||
| Completion Date | February 2008 | ||||
| Estimated Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00628511 | ||||
| Other Study ID Numbers ICMJE | 6902256 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | To K W, The Hospital Authority | ||||
| Study Sponsor ICMJE | Chinese University of Hong Kong | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Chinese University of Hong Kong | ||||
| Verification Date | February 2008 | ||||
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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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