Objective Sleep Disturbances in Orthostatic Intolerance

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
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
  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Satish R Raj, MD MSCI Vanderbilt University
  More Information

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

ClinicalTrials.gov processed this record on October 23, 2014