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Active, Not Recruiting

NCT Number: NCT00692471

Sleep Actigraphy in Postural Tachycardia Syndrome (POTS)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Postural Tachycardia Syndrome Autonomic Nervous System Diseases Mental Disorders Nervous System Diseases Neurologic Manifestations Orthostatic Intolerance Pathological Conditions, Signs and Symptoms Postural Orthostatic Tachycardia Syndrome Primary Dysautonomias Signs and Symptoms Sleep Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University

Nashville, Tennessee, 37232-2195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ActiWatch from Minimitter

Primary outcomes

  1. Sleep Latency

    Time frame: 1 week

Secondary outcomes

  1. Sleep Efficiency

    Time frame: 1 week

  2. Wake After Sleep Onset

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Satish R. Raj

Other

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Official study title

Assessment of Objective Sleep Disturbances in Orthostatic Intolerance Using Actigraphy

Important dates

Study start
2008
Primary completion
2029
Study completion
2029
First posted
Jun 6, 2008
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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