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Objective Sleep Disturbances in Orthostatic Intolerance

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
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
History of Changes
  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:

U.S. FDA Resources

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 2014
Estimated Primary Completion Date: December 2014 (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

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581022

Locations
United States, Tennessee
Vanderbilt Unviersity
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Satish R. Raj
National Institutes of Health (NIH)
Investigators
Principal Investigator: Satish R Raj, MD MSCI Vanderbilt University
  More Information

Additional Information:
Vanderbilt Autonomic Dysfunction Center  This link exits the ClinicalTrials.gov site

No publications provided

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: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
postural tachycardia syndrome
sleep
insomnia

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

ClinicalTrials.gov processed this record on May 16, 2013