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Sleep Actigraphy in Postural Tachycardia Syndrome (POTS)

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:
NCT00692471
First received: June 2, 2008
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

We propose to use actigraphy (measured by activity watches) as a tool to quantify sleep disturbances in patients with orthostatic intolerance compared with healthy control subjects. In this pilot study, we will test the null hypothesis (Ho) that there are no differences in the sleep quality between patients with orthostatic intolerance and healthy control subjects.


Condition Intervention
Postural Tachycardia Syndrome
Orthostatic Intolerance
Sleep Disorders
 Device: Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Objective Sleep Disturbances in Orthostatic Intolerance Using Actigraphy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Sleep Latency [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep Efficiency [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Wake After Sleep Onset [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2008
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 meeting the diagnostic criteria for the Postural Tachycardia Syndrome, a form of Orthostatic Intolerance
 Device: Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter
Watch to be worn on wrist for 7 days (except in water) that will measure activity/movement.
Other Name: ActiWatch from Minimitter
2
Healthy control subjects who do not meet the criteria for the Postural Tachycardia Syndrome
 Device: Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter
Watch to be worn on wrist for 7 days (except in water) that will measure activity/movement.
Other Name: ActiWatch from Minimitter

  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 the Postural Tachycardia Syndrome. The criteria include:

  • an increase in heart rate on standing (from supine) of >30 bpm
  • in the setting of symptoms of cerebral hypoperfusion that are worse with standing and better when recumbent
  • the symptoms are daily or almost daily
  • the symptoms are chronic (lasting greater than 6 motnsh)
Criteria

Inclusion Criteria:

  • Diagnosed with orthostatic intolerance by the Vanderbilt Autonomic Dysfunction Center
  • Control subjects will be free of orthostatic intolerance and other major medical problems, free of medications during the study
  • Age between 18-65 years
  • Male and female subjects are eligible.
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Overt cause for postural tachycardia (such as acute dehydration)
  • Self-report of pregnancy
  • Inability to give, or withdrawal of, informed consent
  • Other factors which in the investigator's opinion would prevent the subject from completing the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692471

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232-2195
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 Website  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: NCT00692471     History of Changes
Other Study ID Numbers: 080233, K23 RR020783
Study First Received: June 2, 2008
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Sleep
Orthostatic tachycardia
POTS

Additional relevant MeSH terms:
Orthostatic Intolerance
Mitral Valve Prolapse
Neurocirculatory Asthenia
Sleep Disorders
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 19, 2013