Sleep Actigraphy in Postural Tachycardia Syndrome (POTS)

NCT00692471 | Active Not Recruiting

• 2 other identifiers: 080233K23RR020783
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postural Tachycardia Syndrome; Orthostatic Intolerance; Sleep Disorders

Keywords

Sleep; Orthostatic tachycardia; POTS

Outcome Measures

Primary Outcomes (1)

• Sleep Latency

  1 week

Secondary Outcomes (2)

• Sleep Efficiency

  1 week

• Wake After Sleep Onset

  1 week

Study Arms (2)

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

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

Interventions

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

Watch to be worn on wrist for 7 days (except in water) that will measure activity/movement.

Also known as: ActiWatch from Minimitter

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Satish R. Raj: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232-2195, United States

Location

Related Links

• Vanderbilt Autonomic Dysfunction Center Website

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Orthostatic Intolerance; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Satish R Raj, MD MSCI

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine & Pharmacology

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 6, 2008
• Study Start: June 1, 2008
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 8, 2025

Record last verified: 2025-10

Locations

US (1)