Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Treatment Method for Sjogren's Syndrom… (NCT06626477) | Clinical Trial Compass
CompletedNot Applicable
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Treatment Method for Sjogren's Syndrome (SS)
Sweden26 participantsStarted 2024-11-05
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years at inclusion date
✓. Schirmer's test ≤ 5 mm for both eyes
✓. NIBUT ≤ 10 s for both eyes
✓. Previous positive result of blood test for sample anti-Ro (SS-A) or anti-La (SS-B), as indicated by medical record or lab result shown by the subject.
✓. The study subject reports having understood and have signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments.
✓. Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study.
✓. Anticipated compliance with prescribed treatment and follow-up.
✕. Presence of an ocular or respiratory condition that could affect the study parameters such as active ocular infection/inflammation, glaucoma, diabetic retinopathy, or upper respiratory tract infection per the Investigator's judgement.
What they're measuring
1
Change from baseline in the mean Schirmer's test at six weeks