- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00581022
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
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
-
-
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
|
Overnight Sleep Study
Other Names:
|
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
Collaborators
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
- Mental Disorders
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Nervous System Diseases
- Sleep Wake Disorders
- Neurologic Manifestations
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Autonomic Nervous System Diseases
- Primary Dysautonomias
- Dyssomnias
- Parasomnias
- Tachycardia
- Postural Orthostatic Tachycardia Syndrome
- Orthostatic Intolerance
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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