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

NCT06626477 | Completed

• 2 other identifiers: A-SS-001CIV-24-05-047403
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sjogren Syndrome

Keywords

INMEST; Abilion

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the mean Schirmer's test at six weeks

  Change in mean tear production using Schirmer's test comparing active treatment (active) vs sham treatment (control) evaluated at baseline (Day 0) and week 6 (Day 42) comparing active and sham treatment.

  From enrollment to week 6

Secondary Outcomes (16)

• Adverse Events

  From enrollment to the end of treatment at 12 weeks

• Device Deficiencies

  From enrollment to the end of treatment at 12 weeks

• Change from baseline in the mean Best-Corrected Visual Acuity (BCVA) at six weeks

  From enrollment to week 6

• Change from baseline in the mean Non-invasive Break-Up (NIBUT) time at six weeks

  From enrollment to week 6

• Change from baseline in the mean Fluorescein Eye Stain Test at six weeks

  From enrollment to week 6

Study Arms (2)

Active (6 weeks) + Active (6 weeks)

EXPERIMENTAL

Randomized, double-blinded, active treatment for 6 weeks, then 6 weeks of unblinded active treatment.

Device: Intra nasal mechanical stimulation treatment (INMEST)

Sham (6 weeks) + Active (6 weeks)

SHAM COMPARATOR

Randomized, double-blinded, sham treatment for 6 weeks, then 6 weeks of unblinded active treatment.

Device: Intra nasal mechanical stimulation treatment (INMEST); Device: Sham (No Treatment)

Interventions

Intra nasal mechanical stimulation treatment (INMEST) DEVICE

The treatment is performed with the Walther System manufactured by Abilion Medical Systems AB.

Also known as: INMEST

Active (6 weeks) + Active (6 weeks); Sham (6 weeks) + Active (6 weeks)

Sham (No Treatment) DEVICE

A modified Walther System not delivering active treatment manufactured by Abilion Medical Systems AB.

Sham (6 weeks) + Active (6 weeks)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Abilion Medical Systems AB: lead
• Insamlingsstiftelsen för främjande av forskning avseende INMEST: collaborator

Study Sites (1)

Källmarkskliniken AB

Solna, Stockholm County, 171 54, Sweden

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Fredrik Källmark, PhD

  Källmarkskliniken AB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Manufacturer, Monitor
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: During the first half (6 weeks) the subjects receive either active or sham treatment (randomized). During the final half (6 weeks) all subjects receive active treatment.

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 3, 2024
• Study Start: November 5, 2024
• Primary Completion: July 19, 2025
• Study Completion: July 19, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)