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Objective Sleep Disturbances in Orthostatic Intolerance

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ClinicalTrials.gov Identifier: NCT00581022
Recruitment Status : Completed
First Posted : December 27, 2007
Last Update Posted : March 27, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Postural Tachycardia Syndrome Chronic Orthostatic Intolerance Procedure: Polysomnography

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Objective Sleep Disturbances in Orthostatic Intolerance
Study Start Date : November 2006
Primary Completion Date : December 2016
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
1
Patients with Chronic Orthostatic Intolerance
Procedure: Polysomnography
Overnight Sleep Study
Other Name: Sleep Study


Outcome Measures

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

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

Eligibility Criteria

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

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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 Posted: December 27, 2007    Key Record Dates
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
Postural Orthostatic Tachycardia Syndrome
Dyssomnias
Sleep Wake Disorders
Parasomnias
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