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临床试验/NCT04562519
NCT04562519Unknown不适用

Hyposalivation Response to TENS in HD Patients

Cairo University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
3-week response of salivary flow rate

研究概览

简要总结

Xerostomia is a subjective complaint of dry mouth, whereas hyposalivation is an objective decreased of salivary flow. Hyposalivation was reported in 28.8 % of haemodialysis (HD) patients (Bruzda-Zwiech, 2014).

详细描述

Stimulation of the salivary glands can be induced mechanically (for example, by chewing gum or acupressure) or through medications (such as pilocarpine, cevimeline, angiotensin-converting-enzyme inhibitors and angiotensin-receptor blockers) or by electrostimulation as transcutnaeous electrical nerve stimulation (TENS) (Bossola and Tazza, 2012).

Eighty HD patients (40 diabetics and 40 nondiabetics) will receive 20 minutes of TENS on skin over bilateral parotid gland, 3 times weekly for 3 weeks to investigate the hyposalivation response of diabetic and non diabetic HD patients to TENS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eighty HD patients (40 diabetics and 40 non diabetics)
  • HD at least from three month
  • saliva flow less than or equal 0.15 millilitre per minute

排除标准

  • pulmonary or cardiac disorders
  • drugs to treat hyposalivation
  • salivary glands inflammation, tumor, and autoimmune diseases.
  • smokers and alcholics

结局指标

主要结局

3-week response of salivary flow rate

时间窗: immediately after the last session

the patients will be ordered to spit saliva in a graduated test tube for 5 minutes after the last session (session number 9). To calculate salivary flow rate: saliva volume will be divided on duration of saliva spitting.

次要结局

  • immediate response of saliva flow(immediately after the first session)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Mohamed Ali ismail

lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Cairo University

研究点 (2)

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