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NCT00581022 Clinical Trial

Objective Sleep Disturbances in Orthostatic Intolerance

Postural Tachycardia Syndrome Clinical Trial

Official title:
Assessment of Objective Sleep Disturbances in Orthostatic Intolerance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00581022
Other study ID # 051131
Secondary ID UL1RR024975
Status Completed
Phase
First received
Last updated
Start date November 2006
Est. completion date December 2016

Study information
Verified date August 2018
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

We wish to study sleep architecture in patients with chronic orthostatic intolerance. We will test the null hypothesis that there is no difference in time during the various phases of sleep between patients and healthy control subjects.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- diagnosed with chronic orthostatic intolerance (or healthy subject)

Exclusion Criteria:

- overt cause or acute orthostatic intolerance

- pregnancy or lactation

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Polysomnography
Overnight Sleep Study

Locations
Country Name City State
United States Vanderbilt Unviersity 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 Duration of sleep 1 night
Secondary Time in individual phases of sleep 1 night
Secondary sleep latency 1 might
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