Sleep Actigraphy in Postural Tachycardia Syndrome (POTS) - Tabular View

Tracking Information

First Received Date ^ICMJE

June 2, 2008

Last Updated Date

August 14, 2009

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sleep Latency [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00692471 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Sleep Actigraphy in Postural Tachycardia Syndrome (POTS)

Official Title ^ICMJE

Assessment of Objective Sleep Disturbances in Orthostatic Intolerance Using Actigraphy

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case Control, Prospective

Condition ^ICMJE

Postural Tachycardia Syndrome
Orthostatic Intolerance
Sleep Disorders

Intervention ^ICMJE

Device: Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter

Study Arms / Comparison Groups

Patients meeting the diagnostic criteria for the Postural Tachycardia Syndrome, a form of Orthostatic Intolerance
Healthy control subjects who do not meet the criteria for the Postural Tachycardia Syndrome

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

June 2011

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Ginnie Farley

ginnie.farley@vanderbilt.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00692471

Responsible Party

Dr. Satish R Raj, Vanderbilt University

Study ID Numbers ^ICMJE

080233, K23 RR020783

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

National Institutes of Health (NIH)

Investigators ^ICMJE

Principal Investigator:

Satish R Raj, MD MSCI

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP