Using intranasal mechanical stimulation to treat Sjogren's syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and effectiveness of the Walther System, which delivers intranasal mechanical stimulation (INMEST), for individuals with Sjogren's syndrome. A total of 30 participants will be enrolled and randomly assigned to either an active device or a sham device for the first six weeks, after which all participants will receive the active treatment for an additional six weeks. Participants will self-administer the treatment at home three times a week for 10 minutes per nostril and will visit the clinic every three weeks for assessments. The study aims to provide symptom relief for this chronic condition that primarily affects moisture-secreting glands.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years at inclusion date
2. Schirmer's test ≤ 5 mm for both eyes
3. NIBUT ≤ 10 s for both eyes
4. 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.
5. 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.
6. Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study.
7. Anticipated compliance with prescribed treatment and follow-up.

Exclusion Criteria:

1. Recently (12 months prior enrolment) undergone nasal, sinus, or ocular surgery.
2. 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.
3. The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation.
4. Any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation.
5. The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason.
6. Previous (within 30 days prior to enrolment) and concurrent treatment with another investigational drug/s or device/s.
7. Subject is pregnant or lactating or planning to get pregnant during the duration of the study.

Where it's running

• Källmarkskliniken AB
  Solna, Stockholm, Sweden Recruiting

Study contacts

• Principal investigator: Fredrik Källmark, PhD — Källmarkskliniken AB
• Study coordinator: Karl-Johan Pantzar
• Email: kj@abilion.com
• Phone: +46-(0)739808065

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.