Using intranasal mechanical stimulation to treat Sjogren's syndrome

Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Treatment Method for Sjogren's Syndrome (SS) - a Prospective, Double-Blind, Randomized Pilot Study To Evaluate the Safety and Performance of the Walther System

This study is testing a new device that delivers nasal stimulation to see if it can help people with Sjogren's syndrome feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Abilion Medical Systems AB (Industry-sponsored)
• Locations: 1 site (Solna, Stockholm)
• Trial ID: NCT06626477 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with Sjogren's syndrome, exhibiting specific ocular dryness symptoms.

Not a fit: Patients who have recently undergone nasal, sinus, or ocular surgery or have active ocular or respiratory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant symptom relief for patients suffering from Sjogren's syndrome.

How similar studies have performed: While this approach is novel, there is limited existing research on intranasal mechanical stimulation for Sjogren's syndrome, making this a potentially groundbreaking investigation.

Eligibility criteria

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 this trial is running

Solna, Stockholm

• Källmarkskliniken AB — Solna, Stockholm, Sweden (Recruiting)

Study contacts

• Principal investigator: Fredrik Källmark, PhD — Källmarkskliniken AB
• Study coordinator: Karl-Johan Pantzar

Conditions Sjogren Syndrome; INMEST; Abilion