Sleep Actigraphy in Postural Tachycardia Syndrome (POTS)

Sponsor

Satish R. Raj (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00692471

Collaborator

National Center for Research Resources (NCRR) (NIH)

100

Enrollment

Location

198

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postural Tachycardia Syndrome Orthostatic Intolerance Sleep Disorders	Device: Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Assessment of Objective Sleep Disturbances in Orthostatic Intolerance Using Actigraphy

Study Start Date :

Jun 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Sleep Latency [1 week]

Secondary Outcome Measures

Sleep Efficiency [1 week]
Wake After Sleep Onset [1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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