Objective Sleep Disturbances in Orthostatic Intolerance

August 9, 2018 updated by: Satish R. Raj

Assessment of Objective Sleep Disturbances in Orthostatic Intolerance

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Unviersity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients diagnosed with chronic orthostatic intolerance by the Vanderbilt Autonomic Dysfunction Center

Description

Inclusion Criteria:

  • diagnosed with chronic orthostatic intolerance (or healthy subject)

Exclusion Criteria:

  • overt cause or acute orthostatic intolerance
  • pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Patients with Chronic Orthostatic Intolerance
Procedure: Polysomnography
Overnight Sleep Study
Other Names:
  • Sleep Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of sleep
Time Frame: 1 night
1 night

Secondary Outcome Measures

Outcome Measure
Time Frame
Time in individual phases of sleep
Time Frame: 1 night
1 night
sleep latency
Time Frame: 1 might
1 might

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Satish R. Raj

Collaborators

National Center for Research Resources (NCRR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 22, 2007

First Submitted That Met QC Criteria

December 22, 2007

First Posted (Estimate)

December 27, 2007

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 051131
  • UL1RR024975 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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