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NCT00565526 · ClinicalTrials.gov registry record
Evaluation of the Role of the Autonomic Nervous System in Sj(SqrRoot)(Delta)Gren s Syndrome
A clinical trial of Sjogren's Syndrome and Dysautonomia, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- 28
- Enrollment target
- 1
- Study location
NCT00565526: Completed study of Sjogren's Syndrome and Dysautonomia, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
NCT00565526 is a study of Sjogren's Syndrome and Dysautonomia that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 28 participants, below the 287-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00565526, a study of Sjogren's Syndrome and Dysautonomia, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Sj(SqrRoot)(Delta)gren s Syndrome (SS) is an autoimmune disease that affects the glands that produce saliva and tears, causing dry eyes and dry mouth. Researchers do not know the exact cause of SS, but they believe that it may be caused by abnormalities in the autonomic nervous system (ANS) that stimulate these glands. Objectives: To better understand ANS function in patients with SS. To compare information about ANS function in healthy individuals and in patients with SS. Eligibility: Patients with Sj(SqrRoot)(Delta)gren s Syndrome who are 18 years of age and older, and who are not pregnant or breastfeeding. Participants will be asked to taper or discontinue the use of certain medications or dietary supplements before the ANS testing. Participants must be willing to discontinue the use of alcohol and tobacco 24 hours prior to testing. Design: The study will require one inpatient admission and/or outpatient visits to the NIH Clinical Center. The following tests and procedures will be performed: * Saliva, tear, and sweat production measurements to evaluate the function of glands. * Testing of changes to the cardiovascular system, including blood pressure and blood flow testing, and an electrocardiogram designed to evaluate hemodynamic changes controlled by the ANS. * Testing of changes to the gastrointestinal system, including a swallowing assessment study, barium swallow study, and gastric emptying study designed to evaluate gastrointestinal function controlled by the ANS. * Tests to evaluate the ANS function in response to certain drugs (edrophonium, glucagon and acetylcholine). * Self-reported questionnaire on ANS function and emotional/psychological well-being. Additional procedures and tests may include the following: * Blood samples. * Optional skin biopsy to study sweat glands and nerve supply of the skin.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2007-11-26 |
| Est. Completion | 2014-04-10 |
What the finished NCT00565526 record still lists
NCT00565526 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 287-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Sjogren's Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT00565526 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00565526 about?
NCT00565526 is a clinical study titled "Evaluation of the Role of the Autonomic Nervous System in Sj(SqrRoot)(Delta)Gren s Syndrome". Background: Sj(SqrRoot)(Delta)gren s Syndrome (SS) is an autoimmune disease that affects the glands that produce saliva and tears, causing dry eyes and dry mouth. Researchers do not know the exact cause of SS, but they believe that it may be caused by abnormalities in the autonomic nervous system ...
What is the current status of trial NCT00565526?
This trial is currently completed. The enrollment target is 28 participants. The study started on 2007-11-26. Estimated completion is 2014-04-10.
What conditions does trial NCT00565526 study?
This clinical trial studies the following conditions: Sjogren's Syndrome, Dysautonomia.
Who is sponsoring clinical trial NCT00565526?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00565526 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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