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Objective Sleep Disturbances in Orthostatic Intolerance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00581022
First Posted: December 27, 2007
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University Medical Center
  Purpose
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.

Condition Intervention
Postural Tachycardia Syndrome Chronic Orthostatic Intolerance Procedure: Polysomnography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Objective Sleep Disturbances in Orthostatic Intolerance

Resource links provided by NLM:


Further study details as provided by Satish R. Raj, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Duration of sleep [ Time Frame: 1 night ]

Secondary Outcome Measures:
  • Time in individual phases of sleep [ Time Frame: 1 night ]
  • sleep latency [ Time Frame: 1 might ]

Estimated Enrollment: 100
Study Start Date: November 2006
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with Chronic Orthostatic Intolerance
Procedure: Polysomnography
Overnight Sleep Study
Other Name: Sleep Study

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients diagnosed with chronic orthostatic intolerance by the Vanderbilt Autonomic Dysfunction Center
Criteria

Inclusion Criteria:

  • diagnosed with chronic orthostatic intolerance (or healthy subject)

Exclusion Criteria:

  • overt cause or acute orthostatic intolerance
  • pregnancy or lactation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581022


Locations
United States, Tennessee
Vanderbilt Unviersity
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Satish R. Raj
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Satish R Raj, MD MSCI Vanderbilt University
  More Information

Additional Information:
Responsible Party: Satish R. Raj, Assistant Professor of Medicine & Pharmacology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00581022     History of Changes
Other Study ID Numbers: 051131
UL1RR024975 ( U.S. NIH Grant/Contract )
First Submitted: December 22, 2007
First Posted: December 27, 2007
Last Update Posted: March 27, 2017
Last Verified: March 2017

Keywords provided by Satish R. Raj, Vanderbilt University Medical Center:
postural tachycardia syndrome
sleep
insomnia

Additional relevant MeSH terms:
Tachycardia
Dyssomnias
Sleep Wake Disorders
Parasomnias
Postural Orthostatic Tachycardia Syndrome
Orthostatic Intolerance
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Primary Dysautonomias
Autonomic Nervous System Diseases