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Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Treatment Method for Sjogren's Syndrome (SS)

Abilion Medical Systems AB · 2024
ClinicalTrials.gov · Datasets · License: Public Domain · 2024
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The purpose of the study is to investigate the effect and safety of the Walther System delivering INMEST (intranasal mechanical stimulation) on people with Sjogren\'s syndrome. A total of 30 subjects are planned to be enrolled and randomized to either use an active device or a sham device for the first 6 weeks. During the last 6 weeks all subjects will receive active treatment. The treatments are self-administered by the subject at home, three times a week and 10 minutes per nostril. Subjects will: * Use an active or sham device at home 3 times per week for six weeks. * All subjects will then get an active device for use another six weeks. * Visit the clinic every third week for measurements and checkups. * Keep a diary of the treatments and potential problems.
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