Sleep Actigraphy in Postural Tachycardia Syndrome (POTS)

September 20, 2023 updated by: Satish R. Raj

Assessment of Objective Sleep Disturbances in Orthostatic Intolerance Using Actigraphy

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-2195
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • 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 Names:
  • ActiWatch from Minimitter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sleep Latency
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Sleep Efficiency
Time Frame: 1 week
1 week
Wake After Sleep Onset
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Satish R. Raj

Collaborators

National Center for Research Resources (NCRR)

Investigators

  • Principal Investigator: Satish R Raj, MD MSCI, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 2, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (Estimated)

June 6, 2008

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 080233
  • K23RR020783 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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