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Sponsored by: |
National Institute of Dental and Craniofacial Research (NIDCR) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00565526 |
Background:
Sjogren'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 Sjogren'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:
Additional procedures and tests may include the following:
Condition |
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Sjogren's Syndrome Dysautonomia |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Clinical and Laboratory Evaluation of the Autonomic Nervous System in Primary Sjogren's Syndrome |
Estimated Enrollment: | 60 |
Study Start Date: | November 2007 |
Sjogren's syndrome (SjS) is a systemic exocrinopathy that affects as high as 5 percent of the population. It is manifested predominantly as dry eyes, dry mouth, and fatigue. The exocrinopathy can be encountered alone (primary SjS) in approximately one half of the patients or in the presence of another autoimmune disorder such as rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis (secondary SjS). The most widely accepted classification for SjS is the American-European consensus classification criteria for SjS. (Vitali, Bombardieri et al. 2002)
Current understanding about the pathogenesis of SjS stems from the assumption that the autoimmune destruction of the exocrine glands leads to their hypofunction and symptoms of dryness. The existing evidence, however, does not fully support this assumption and cannot explain the underlying pathogenic mechanisms of SjS for the following reasons: 1) Discordance between severely affected function and abundance of histologically normal and ex vivo functional salivary glands; 2) at least 20% of patients have no evidence of systemic autoimmunity; 3) Animal models of SjS develop glandular dysfunction long before they develop autoimmunity; 4) Dryness and related symptoms respond poorly to immunosuppressives, including newer biologics, but fairly well to secretagogues such as pilocarpine; 5) No pathogenic antibodies or target epitopes have been identified to date to unify the pathogenesis of the syndrome.
All exocrine glands are innervated by the autonomic nervous system (ANS) and dysautonomia can mimic the phenotype of SjS, particularly cardinal manifestations, such as xerostomia and xerophthalmia. Thus we hypothesize that ANS dysfunction is central to the pathogenesis of SjS and propose to systematically study the ANS function in our cohort of patients with primary SjS compared with normative data from age and sex-matched controls. This protocol calls for a comprehensive evaluation of autonomic function, using physiological, neuropharmacologic, neurochemical, and imaging approaches, to identify consistent distinctive patterns of ANS involvement in SjS and thereby improve the diagnosis and understanding of pathophysiologic mechanisms of SjS.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Exclusion criteria for primary Sjogren's syndrome:
Medications: A candidate subject is excluded if clinical considerations require that the patient continue treatment with a drug likely to interfere with the scientific results i.e. a tricyclic antidepressant or fludrocortisone. Patients with known or suspected allergy or hypersensitivity to any test drug are excluded from receiving that drug. Patients who must take medications daily in the following categories are excluded: tricyclic antidepressants, beta blockers, barbiturates, if they cannot be safely held during testing. Patients unable to discontinue nicotine or alcohol temporarily are excluded. Patients are not to discontinue any medications before the patient or the patient's physician discusses this with the Principal Investigator, Dr. Nikolov, or the Associate Investigator, Dr. Goldstein. If it is decided that discontinuing medications would be unsafe, then the patient is excluded from the study. Subjects must discontinue use of alcohol and tobacco throughout the period of testing in the protocol.
Herbal Medicines and Dietary Supplements: Certain herbal medicines or dietary supplements are known or suspected to interfere with the experimental results, and such herbal medicines or dietary supplements must be discontinued before enrollment in the study. For many herbal medicines or dietary supplements, the mechanisms of action and therefore the possible effects on the experimental results are unknown. In cases where the subjects wish to continue their herbal medicines or dietary supplements while on study, and search of the available medical literature fails to identify effects that are known or expected to interfere with the experimental results, then the subjects may participate.
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 080018, 08-D-0018 |
Study First Received: | November 29, 2007 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00565526 |
Health Authority: | United States: Federal Government |
Autonomic Nervous System Sjogren's Syndrome Pathogenesis |
Cholinergic Parasympathetic Sjogren Syndrome |
Mouth Diseases Autoimmune Diseases Eye Diseases Joint Diseases Arthritis, Rheumatoid Lacrimal Apparatus Diseases Dry Eye Syndromes Rheumatic Diseases |
Xerostomia Autonomic Nervous System Diseases Musculoskeletal Diseases Arthritis Connective Tissue Diseases Sjogren's Syndrome Stomatognathic Diseases Salivary Gland Diseases |
Pathologic Processes Disease Immune System Diseases Syndrome Nervous System Diseases |