Sjogren SyndromeA-SS-001NCT06626477
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Treatment Method for Sjogren's Syndrome (SS)
A study testing Intra nasal mechanical stimulation treatment (INMEST) in people with Sjogren Syndrome, run by Abilion Medical Systems AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren Syndrome
- What is being tested?
- Intra nasal mechanical stimulation treatment (INMEST)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSweden
- Study dates
- 5 Nov 2024to 19 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Clinical investigation purpose and background ----- In this investigation the intended purpose of the investigational device, the Walther System, is to deliver intranasal mechanical stimulation (INMEST) for symptom relief in cases of Sjogren's syndrome, and the treatment is self-administered at home.
Sjogren\'s syndrome is a chronic disorder of the immune system that usually affects the mucous membranes and moisture-secreting glands of the eyes and mouth. The two most common symptoms of Sjogren's Syndrome are dry eyes and a dry mouth. The prevalence has been reported to be 0.06% and the disease mostly affect women and people over 40. There are currently no treatment options for Sjogren\'s syndrome other than relieving symptoms resulting in medications that decrease eye inflammation, increase saliva production, and/or suppress the immune system.
Design of clinical investigation
-----
This is a randomized, double-blinded, single centre, pilot study with a total of 30 study subjects, from 18 years of both genders. Randomization of study subjects is done in permuted blocks and the subjects are randomized to either one of two groups of equal size receiving either:
- treatment with the investigational device (active) B. treatment with comparator device (sham/control) After half the treatment time all subjects are given a new investigational device that is active, thus all subjects will receive active treatment.
After enrolment in the study, including the informed consent procedure, and the subsequent randomization process, study subjects are assigned to either an investigational device treatment (group A) or a comparator treatment group (group B). After an initial demonstration of the device (comparator or investigational device), study subjects will be given the device to be used for self-administration at home, 3 days a week, 10 minutes per nasal cavity (i.e. a total of 20 minutes per treatment session), for a total treatment period of 12 weeks (i.e., a total of 36 treatment sessions). After 6 weeks all subjects, irrespective of group, will exchange their device for an investigational device, thus all subjects will receive active treatment for the last 6 weeks.
Clinic visits with measurements are scheduled at baseline followed at visits after 3, 6, 9, and 12 weeks when end of treatment is reached. Every visit after baseline should be made within a time window of -3 days to +10 days. Subjects are instructed not to perform any treatments with the device 12 hours prior visiting the clinic.
During the study period, both patients' reported symptoms and objective measurements will be collected. An analysis will also be made of compliance with the prescribed treatment and the safety of the investigational medical device will be evaluated through analysis of reported adverse events and device deficiencies.
- Conditions
- Sjogren Syndrome
- Being tested
- Intra nasal mechanical stimulation treatment (INMEST), Sham (No Treatment)
- Keywords
- INMEST, Abilion
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra nasal mechanical stimulation treatment (INMEST)Device
Also called INMEST
The treatment is performed with the Walther System manufactured by Abilion Medical Systems AB.
Sham (No Treatment)Device
A modified Walther System not delivering active treatment manufactured by Abilion Medical Systems AB.
| Study group | Role | What they receive |
|---|---|---|
| Active (6 weeks) + Active (6 weeks) | Experimental | Randomized, double-blinded, active treatment for 6 weeks, then 6 weeks of unblinded active treatment. Receives: 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. Receives: Device: Intra nasal mechanical stimulation treatment (INMEST); Device: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to week 6
Secondary outcomes (16)
Adverse Events
Number of treatment related Adverse Events/Adverse Device Effects/Serious Adverse Events/Serious Adverse Device Effects and Unanticipated Serious Adverse Device Effects when using the Walther System.
Measured: From enrollment to the end of treatment at 12 weeks
Device Deficiencies
Number of Walther System Device Deficiencies.
Measured: From enrollment to the end of treatment at 12 weeks
Change from baseline in the mean Best-Corrected Visual Acuity (BCVA) at six weeks
Change in mean Best-Corrected Visual Acuity (BCVA) using a Snellen equivalent chart evaluated at baseline (Day 0) and week 6 (Day 42) comparing active and sham treatment.
Measured: From enrollment to week 6
Change from baseline in the mean Non-invasive Break-Up (NIBUT) time at six weeks
Change in mean Non-invasive Break-Up time (NIBUT) evaluated at baseline (Day 0) and week 6 (Day 42) comparing active and sham treatment.
Measured: From enrollment to week 6
Change from baseline in the mean Fluorescein Eye Stain Test at six weeks
Change in Fluorescein Eye Stain Test evaluated at baseline (Day 0) and week 6 (Day 42) comparing active and sham treatment.
Measured: From enrollment to week 6
Change from baseline in Matrix Metalloproteinase-9 (MMP-9) at six weeks
Change in Matrix Metalloproteinase-9 (MMP-9) evaluated at baseline (Day 0) and week 6 (Day 42) comparing active and sham treatment.
Measured: From enrollment to week 6
Change from baseline in the mean salivary flow rate time at six weeks
Change in mean salivary flow rate evaluated at baseline (Day 0) and week 6 (Day 42) comparing active and sham treatment.
Measured: From enrollment to week 6
Change from baseline in the mean EULAR Sjogrens Syndrome Patient Reported Index (ESSPRI) at six weeks
Self-experienced change in mean EULAR Sjogrens Syndrome Patient Reported Index (ESSPRI) evaluated at baseline (Day 0) and week 6 (Day 42) comparing active and sham treatment.
Measured: From enrollment to week 6
Change from baseline in the mean Ocular Surface Disease Index (OSDI) at 6 weeks
Self-experienced change in Ocular Surface Disease Index (OSDI) evaluated at baseline (Day 0) and week 6 (Day 42) comparing active and sham treatment.
Measured: From enrollment to week 6
Change in the mean Schirmers test between six and twelve weeks active treatment
Change in mean tear production using Schirmer's test comparing active group (12 weeks) with control group (6 last weeks of active treatment).
Measured: From enrollment to week 12 (Active) and from week 7 to 12 (Control)
Change in the mean Best-Corrected Visual Acuity (BCVA) between six and twelve weeks active treatment
Change in Best-Corrected Visual Acuity (BCVA) using a Snellen equivalent chart comparing active group (12 weeks) with control group (6 last weeks of active treatment).
Measured: From enrollment to week 12 (Active) and from week 7 to 12 (Control)
Change in the mean Fluorescein Eye Stain Test between six and twelve weeks active treatment
Change in mean Fluorescein Eye Stain Test evaluated at baseline (Day 0) and week 6 (Day 42) comparing active group (12 weeks) with control group (6 last weeks of active treatment).
Measured: From enrollment to week 12 (Active) and from week 7 to 12 (Control)
Change in Matrix Metalloproteinase-9 (MMP-9) between six and twelve weeks active treatment
Change in Matrix Metalloproteinase-9 (MMP-9) evaluated at baseline (Day 0) and week 6 (Day 42) comparing active group (12 weeks) with control group (6 last weeks of active treatment).
Measured: From enrollment to week 12 (Active) and from week 7 to 12 (Control)
Change in the mean salivary flow rate time between six and twelve weeks active treatment
Change in mean salivary flow rate comparing active group (12 weeks) with control group (6 last weeks of active treatment).
Measured: From enrollment to week 12 (Active) and from week 7 to 12 (Control)
Change in the mean EULAR Sjogrens Syndrome Patient Reported Index (ESSPRI) between six and twelve weeks active treatment
Self-experienced change in mean EULAR Sjogrens Syndrome Patient Reported Index (ESSPRI) comparing active group (12 weeks) with control group (6 last weeks of active treatment).
Measured: From enrollment to week 12 (Active) and from week 7 to 12 (Control)
Change in the mean Ocular Surface Disease Index (OSDI) between six and twelve weeks active treatment
Self-experienced change in mean Ocular Surface Disease Index (OSDI) comparing active group (12 weeks) with control group (6 last weeks of active treatment).
Measured: From enrollment to week 12 (Active) and from week 7 to 12 (Control)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start5 Nov 2024
- Primary completion19 Jul 2025
- Study completion19 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abilion Medical Systems AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Insamlingsstiftelsen för främjande av forskning avseende INMEST
- Responsible party
- Sponsor
- Investigators
- Fredrik Källmark, PhD, Principal investigator, Källmarkskliniken AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626477
- Sponsor's protocol ID
- A-SS-001
- Other IDs
- CIV-24-05-047403
- Acronym
- A-SS-001
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06626477
- Acronym / sponsor ID
- A-SS-001 / A-SS-001
- Conditions
- Sjogren Syndrome
- Keywords
- INMEST, Abilion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Abilion Medical Systems ABIndustry (pharma, biotech, devices)
- Collaborators
- Insamlingsstiftelsen för främjande av forskning avseende INMEST
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 19 Jul 2025 (actual)
- Study completion
- 19 Jul 2025 (actual)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Clinical investigation purpose and background ----- In this investigation the intended purpose of the investigational device, the Walther System, is to deliver intranasal mechanical stimulation (INMEST) for symptom relief in cases of Sjogren's syndrome, and the treatment is self-administered at home.
Sjogren\'s syndrome is a chronic disorder of the immune system that usually affects the mucous membranes and moisture-secreting glands of the eyes and mouth. The two most common symptoms of Sjogren's Syndrome are dry eyes and a dry mouth. The prevalence has been reported to be 0.06% and the disease mostly affect women and people over 40. There are currently no treatment options for Sjogren\'s syndrome other than relieving symptoms resulting in medications that decrease eye inflammation, increase saliva production, and/or suppress the immune system.
Design of clinical investigation
-----
This is a randomized, double-blinded, single centre, pilot study with a total of 30 study subjects, from 18 years of both genders. Randomization of study subjects is done in permuted blocks and the subjects are randomized to either one of two groups of equal size receiving either:
- treatment with the investigational device (active) B. treatment with comparator device (sham/control) After half the treatment time all subjects are given a new investigational device that is active, thus all subjects will receive active treatment.
After enrolment in the study, including the informed consent procedure, and the subsequent randomization process, study subjects are assigned to either an investigational device treatment (group A) or a comparator treatment group (group B). After an initial demonstration of the device (comparator or investigational device), study subjects will be given the device to be used for self-administration at home, 3 days a week, 10 minutes per nasal cavity (i.e. a total of 20 minutes per treatment session), for a total treatment period of 12 weeks (i.e., a total of 36 treatment sessions). After 6 weeks all subjects, irrespective of group, will exchange their device for an investigational device, thus all subjects will receive active treatment for the last 6 weeks.
Clinic visits with measurements are scheduled at baseline followed at visits after 3, 6, 9, and 12 weeks when end of treatment is reached. Every visit after baseline should be made within a time window of -3 days to +10 days. Subjects are instructed not to perform any treatments with the device 12 hours prior visiting the clinic.
During the study period, both patients' reported symptoms and objective measurements will be collected. An analysis will also be made of compliance with the prescribed treatment and the safety of the investigational medical device will be evaluated through analysis of reported adverse events and device deficiencies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active (6 weeks) + Active (6 weeks) | Experimental | Device: Intra nasal mechanical stimulation treatment (INMEST)Randomized, double-blinded, active treatment for 6 weeks, then 6 weeks of unblinded active treatment. |
| Sham (6 weeks) + Active (6 weeks) | Sham comparator | Device: Intra nasal mechanical stimulation treatment (INMEST), Device: Sham (No Treatment)Randomized, double-blinded, sham treatment for 6 weeks, then 6 weeks of unblinded active treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra nasal mechanical stimulation treatment (INMEST)Also: INMESTThe treatment is performed with the Walther System manufactured by Abilion Medical Systems AB. | Device | Active (6 weeks) + Active (6 weeks), Sham (6 weeks) + Active (6 weeks) |
| Sham (No Treatment)A modified Walther System not delivering active treatment manufactured by Abilion Medical Systems AB. | Device | Sham (6 weeks) + Active (6 weeks) |
Primary outcome
Change from baseline in the mean Schirmer's test at six weeks
Time frame: From enrollment to week 6
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.
16 secondary outcomes
Adverse Events
Time frame: From enrollment to the end of treatment at 12 weeks
Device Deficiencies
Time frame: From enrollment to the end of treatment at 12 weeks
Change from baseline in the mean Best-Corrected Visual Acuity (BCVA) at six weeks
Time frame: From enrollment to week 6
Change from baseline in the mean Non-invasive Break-Up (NIBUT) time at six weeks
Time frame: From enrollment to week 6
Change from baseline in the mean Fluorescein Eye Stain Test at six weeks
Time frame: From enrollment to week 6
Change from baseline in Matrix Metalloproteinase-9 (MMP-9) at six weeks
Time frame: From enrollment to week 6
Change from baseline in the mean salivary flow rate time at six weeks
Time frame: From enrollment to week 6
Change from baseline in the mean EULAR Sjogrens Syndrome Patient Reported Index (ESSPRI) at six weeks
Time frame: From enrollment to week 6
Change from baseline in the mean Ocular Surface Disease Index (OSDI) at 6 weeks
Time frame: From enrollment to week 6
Change in the mean Schirmers test between six and twelve weeks active treatment
Time frame: From enrollment to week 12 (Active) and from week 7 to 12 (Control)
Change in the mean Best-Corrected Visual Acuity (BCVA) between six and twelve weeks active treatment
Time frame: From enrollment to week 12 (Active) and from week 7 to 12 (Control)
Change in the mean Fluorescein Eye Stain Test between six and twelve weeks active treatment
Time frame: From enrollment to week 12 (Active) and from week 7 to 12 (Control)
Change in Matrix Metalloproteinase-9 (MMP-9) between six and twelve weeks active treatment
Time frame: From enrollment to week 12 (Active) and from week 7 to 12 (Control)
Change in the mean salivary flow rate time between six and twelve weeks active treatment
Time frame: From enrollment to week 12 (Active) and from week 7 to 12 (Control)
Change in the mean EULAR Sjogrens Syndrome Patient Reported Index (ESSPRI) between six and twelve weeks active treatment
Time frame: From enrollment to week 12 (Active) and from week 7 to 12 (Control)
Change in the mean Ocular Surface Disease Index (OSDI) between six and twelve weeks active treatment
Time frame: From enrollment to week 12 (Active) and from week 7 to 12 (Control)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredrik Källmark, PhD principal investigator
Källmarkskliniken AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra nasal mechanical stimulation treatment (INMEST) in people with Sjogren Syndrome, run by Abilion Medical Systems AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the mean Schirmer's test at six weeks (time frame: From enrollment to week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.