ISRCTN52105758已完成未知
SALivary electro-stimulation for the treatment of dry mouth in patients with Sjogren's syndrome: a multicentRe randomISEd sham-controlled double-blind study
niversity College London0 个研究点目标入组 136 人开始时间: 2018年8月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 136
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients aged =18 years at the time of signing the Informed Consent Form
- •2. Patients with diagnosis of primary Sjögren’s syndrome (pSS) according to 2002 EU/US or 2016 ACR/EULAR classification criteria
- •3. Symptomatic oral dryness (>5/10 on patient-completed Numerical Rating Scale)
- •4. Evidence of residual salivary gland function, demonstrated by an increase in salivary flow on appropriate stimulation (e.g. chewing paraffin wax) as compared to the unstimulated salivary flow
- •5. Unstimulated whole salivary flow higher than 0 ml/5min (unstimulated whole salivary flow as measured via sialometry for 5 minutes)
- •6. Patient has provided written informed consent
排除标准
- •1. Patient has a cardiac pacemaker or other implanted electrostimulating device fitted, e.g. deep brain stimulation device, a cardiac defibrillator
- •2. Patient has epileptic disorder, essential tremor, involuntary muscle movement disorder, e.g. Parkinson’s disease or trigeminal neuralgia
- •3. Patient has evidence of chronic erosive/ulcerative disease or chronic keratotic disorders of the oral mucosa (e.g. lichen planus) or jaw osteonecrosis upon oral examination
- •4. Patient has suspected or confirmed malignant disease or pre-malignancy (dysplasia) of the oral mucosa
- •5. Patient has active malignancy (any organ other than the oral mucosa)
- •6. Current pregnancy as confirmed by urine pregnancy test at Eligibility and Baseline Assessment visit
- •7. Pilocarpine therapy during the 14 days prior to the Eligibility and Baseline Assessment visit
- •8. Concomitant use of systemic sialogogue therapy (e.g. pilocarpine) throughout the study
- •9. Unstable dose over the 4 weeks prior to the Eligibility and Baseline Assessment visit of any medication or therapy known to have an effect upon saliva production (or 7 days in the case of antihistamines)
- •10. Patient has received a rituximab infusion within the 6 months prior to the Eligibility and Baseline Assessment visit
- •11. Patient has received acupuncture for the dry mouth symptoms of pSS within the 28 days prior to the Eligibility and Baseline Assessment visit
- •12. Patient previously participated in LEONIDAS-1, already owns a SaliPen device, any of the earlier generations of the device or any other device with a similar electrostimulatory mode of action that acts upon the salivary glands.
- •13. Expected non-compliance with treatment interventions or is considered unsuitable for trial participation at the discretion of the treating clinician/nurse
研究者
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