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

NCT06626477 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-09-03

No results posted yet for this study

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

Interventions

DEVICE

Intra nasal mechanical stimulation treatment (INMEST)

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

DEVICE

Sham (No Treatment)

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

Sponsors & Collaborators

  • Insamlingsstiftelsen för främjande av forskning avseende INMEST

    collaborator UNKNOWN

  • Abilion Medical Systems AB

    lead INDUSTRY

Principal Investigators

  • Fredrik Källmark, PhD · Källmarkskliniken AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-05
Primary Completion
2025-07-19
Completion
2025-07-19

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06626477 on ClinicalTrials.gov