Objective Sleep Disturbances in Orthostatic Intolerance

This study is ongoing, but not recruiting participants.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
First received: December 22, 2007
Last updated: December 18, 2014
Last verified: December 2014
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 Vanderbilt University:

Primary Outcome Measures:
  • Duration of sleep [ Time Frame: 1 night ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time in individual phases of sleep [ Time Frame: 1 night ] [ Designated as safety issue: No ]
  • sleep latency [ Time Frame: 1 might ] [ Designated as safety issue: No ]

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


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

Inclusion Criteria:

  • diagnosed with chronic orthostatic intolerance (or healthy subject)

Exclusion Criteria:

  • overt cause or acute orthostatic intolerance
  • pregnancy or lactation
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00581022

United States, Tennessee
Vanderbilt Unviersity
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Satish R. Raj
National Institutes of Health (NIH)
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
ClinicalTrials.gov Identifier: NCT00581022     History of Changes
Other Study ID Numbers: 051131  NIH 1 UL1 RR024975 
Study First Received: December 22, 2007
Last Updated: December 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
postural tachycardia syndrome

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

ClinicalTrials.gov processed this record on May 25, 2016