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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change from baseline in the mean Schirmer's test at six weeks
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Manufacturer, Monitor
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change from baseline in the mean Schirmer's test at six weeks
时间窗: 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.
次要结局
- Change from baseline in the mean salivary flow rate time at six weeks(From enrollment to week 6)
- Change from baseline in the mean EULAR Sjogrens Syndrome Patient Reported Index (ESSPRI) at six weeks(From enrollment to week 6)
- 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)
- Change from baseline in Matrix Metalloproteinase-9 (MMP-9) at six weeks(From enrollment to week 6)
- Change from baseline in the mean Ocular Surface Disease Index (OSDI) at 6 weeks(From enrollment to week 6)
- Change in the mean Schirmers test between six and twelve weeks active treatment(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(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(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(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(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(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(From enrollment to week 12 (Active) and from week 7 to 12 (Control))