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Sponsors and Collaborators: |
Vanderbilt University National Institutes of Health (NIH) |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00692471 |
We propose to use actigraphy (measured by activity watches) as a tool to quantify sleep disturbances in patients with orthostatic intolerance compared with healthy control subjects. In this pilot study, we will test the null hypothesis (Ho) that there are no differences in the sleep quality between patients with orthostatic intolerance and healthy control subjects.
Condition | Intervention |
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Postural Tachycardia Syndrome Orthostatic Intolerance Sleep Disorders |
Device: Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Assessment of Objective Sleep Disturbances in Orthostatic Intolerance Using Actigraphy |
Estimated Enrollment: | 100 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Patients meeting the diagnostic criteria for the Postural Tachycardia Syndrome, a form of Orthostatic Intolerance
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Device: Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter
Watch to be worn on wrist for 7 days (except in water) that will measure activity/movement.
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2
Healthy control subjects who do not meet the criteria for the Postural Tachycardia Syndrome
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Device: Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter
Watch to be worn on wrist for 7 days (except in water) that will measure activity/movement.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Patients diagnosed with the Postural Tachycardia Syndrome. The criteria include:
Inclusion Criteria:
Exclusion Criteria:
Contact: Ginnie Farley | ginnie.farley@vanderbilt.edu |
United States, Tennessee | |
Vanderbilt University | Recruiting |
Nashville, Tennessee, United States, 37232-2195 | |
Principal Investigator: Satish R Raj, MD MSCI |
Principal Investigator: | Satish R Raj, MD MSCI | Vanderbilt University |
Responsible Party: | Vanderbilt University ( Dr. Satish R Raj ) |
Study ID Numbers: | 080233, K23 RR020783 |
Study First Received: | June 2, 2008 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00692471 |
Health Authority: | United States: Institutional Review Board |
Sleep Orthostatic tachycardia POTS |
Heart Diseases Orthostatic intolerance Asthenia Tachycardia Sleep Disorders Dyssomnias Marijuana Abuse Prolapse Heart Valve Diseases |
Signs and Symptoms Anxiety Disorders Mitral Valve Prolapse Mental Disorders Neurologic Manifestations Postural orthostatic tachycardia syndrome Neurocirculatory Asthenia Arrhythmias, Cardiac |
Pathologic Processes Disease Syndrome |
Nervous System Diseases Cardiovascular Diseases Heart Valve Prolapse |