CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT00565526
NCT00565526N/ACompleted

Clinical and Laboratory Evaluation of the Autonomic Nervous System in Primary Sjogren's Syndrome

National Institute of Dental and Craniofacial Research (NIDCR)·observational·Posted Nov 30, 2007·Updated Jul 5, 2018

In Brief

An observational study for Sjogren's Syndrome and Dysautonomia. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 30, 2007
Enrollment StartNov 26, 2007
Study CompletionApr 10, 2014
TodayJul 2, 2026
Posted 18.6 years ago