Sleep Actigraphy in Postural Tachycardia Syndrome (POTS) - Full Text View

Sponsor:	Vanderbilt University
Collaborator:	National Institutes of Health (NIH)
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00692471

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:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Marijuana Mitral Valve Prolapse Sleep Disorders

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 2012
Estimated Primary Completion Date:	December 2012 (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

Contacts

Contact: Ginnie Farley

ginnie.farley@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt University	Recruiting
Nashville, Tennessee, United States, 37232-2195
Principal Investigator: Satish R Raj, MD MSCI

Sponsors and Collaborators

Vanderbilt University

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:	Dr. Satish R Raj, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00692471 History of Changes
Other Study ID Numbers:	080233, K23 RR020783
Study First Received:	June 2, 2008
Last Updated:	June 24, 2011
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 February 09, 2012