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
• 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
• 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

Related Conditions & MeSH terms

• Orthostatic Intolerance
• Postural Orthostatic Tachycardia Syndrome
• Postural Tachycardia Syndrome
• Sleep Disorders
• Sleep Wake Disorders
• Syndrome
• Tachycardia

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

External Links

•   Vanderbilt Autonomic Dysfunction Center Website