Sleep Actigraphy in Postural Tachycardia Syndrome (POTS)

Active, not recruiting

• Conditions: Orthostatic Intolerance; Sleep Disorders; Postural Tachycardia Syndrome
• Interventions: Device: Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter

• Registration Number: NCT00692471
• Lead Sponsor: Satish R. Raj

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

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-02
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter	Healthy control subjects who do not meet the criteria for the Postural Tachycardia Syndrome
1	Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter	Patients meeting the diagnostic criteria for the Postural Tachycardia Syndrome, a form of Orthostatic Intolerance

Primary Outcome Measures

Name	Time	Method
Sleep Latency	1 week

Secondary Outcome Measures

Name	Time	Method
Wake After Sleep Onset	1 week
Sleep Efficiency	1 week

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States