Evaluation of the Role of the Autonomic Nervous System in Sj(SqrRoot)(Delta)Gren s Syndrome
Public ClinicalTrials.gov record NCT00565526. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Clinical and Laboratory Evaluation of the Autonomic Nervous System in Primary Sjogren's Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00565526
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 28 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 25, 2007
- Primary completion
- Not listed
- Completion
- Apr 9, 2014
- Last update posted
- Jul 4, 2018
2007 – 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00565526, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 4, 2018 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00565526 live on ClinicalTrials.gov.