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NCT00692471 Clinical Trial

Sleep Actigraphy in Postural Tachycardia Syndrome (POTS)

Sleep Disorders Clinical Trial

Official title:
Assessment of Objective Sleep Disturbances in Orthostatic Intolerance Using Actigraphy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00692471
Other study ID # 080233
Secondary ID K23RR020783
Status Active, not recruiting
Phase
First received
Last updated
Start date June 2008
Est. completion date December 2025

Study information
Verified date September 2023
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Vanderbilt University Nashville Tennessee

Sponsors (2)
Lead Sponsor Collaborator
Satish R. Raj National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sleep Latency 1 week
Secondary Sleep Efficiency 1 week
Secondary Wake After Sleep Onset 1 week
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