Objective Sleep Disturbances in Orthostatic Intolerance
This study is ongoing, but not recruiting participants.
Sponsor:
Satish R. Raj
Collaborator:
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00581022
First received: December 22, 2007
Last updated: January 7, 2013
Last verified: January 2013
| Tracking Information | |||||
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| First Received Date ICMJE | December 22, 2007 | ||||
| Last Updated Date | January 7, 2013 | ||||
| Start Date ICMJE | November 2006 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Duration of sleep [ Time Frame: 1 night ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00581022 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Objective Sleep Disturbances in Orthostatic Intolerance | ||||
| Official Title ICMJE | Assessment of Objective Sleep Disturbances in Orthostatic Intolerance | ||||
| Brief Summary | We wish to study sleep architecture in patients with chronic orthostatic intolerance. We will test the null hypothesis that there is no difference in time during the various phases of sleep between patients and healthy control subjects. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | patients diagnosed with chronic orthostatic intolerance by the Vanderbilt Autonomic Dysfunction Center |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Polysomnography
Overnight Sleep Study
Other Name: Sleep Study |
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| Study Group/Cohort (s) | 1
Patients with Chronic Orthostatic Intolerance
Intervention: Procedure: Polysomnography |
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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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00581022 | ||||
| Other Study ID Numbers ICMJE | 051131, NIH 1 UL1 RR024975 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Satish R. Raj, Vanderbilt University | ||||
| Study Sponsor ICMJE | Satish R. Raj | ||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||
| Investigators ICMJE |
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| Information Provided By | Vanderbilt University | ||||
| Verification Date | January 2013 | ||||
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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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