Overview

This trial is active, not recruiting.

Conditions postural tachycardia syndrome, orthostatic intolerance, sleep disorders
Treatment actigraphy watch (motion sensors) with light sensors - actiwatch from minimitter
Sponsor Satish R. Raj
Collaborator National Center for Research Resources (NCRR)
Start date June 2008
End date December 2016
Trial size 100 participants
Trial identifier NCT00692471, 080233, K23RR020783

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Patients meeting the diagnostic criteria for the Postural Tachycardia Syndrome, a form of Orthostatic Intolerance
actigraphy watch (motion sensors) with light sensors - actiwatch from minimitter ActiWatch from Minimitter
Watch to be worn on wrist for 7 days (except in water) that will measure activity/movement.
Healthy control subjects who do not meet the criteria for the Postural Tachycardia Syndrome
actigraphy watch (motion sensors) with light sensors - actiwatch from minimitter ActiWatch from Minimitter
Watch to be worn on wrist for 7 days (except in water) that will measure activity/movement.

Primary Outcomes

Measure
Sleep Latency
time frame: 1 week

Secondary Outcomes

Measure
Sleep Efficiency
time frame: 1 week
Wake After Sleep Onset
time frame: 1 week

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Assessment of Objective Sleep Disturbances in Orthostatic Intolerance Using Actigraphy
Principal investigator Satish R Raj, MD MSCI
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Vanderbilt University.