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临床试验/NCT02451241
NCT02451241已完成不适用

The Role of Acupuncture for the Treatment of Obstructive Sleep Apnea in Patients With Hypertension

University of Pernambuco1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2015年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Apnea-hypopnea index (AHI)

研究概览

简要总结

Recent evidences from small studies show potential benefit of acupuncture in the treatment of obstructive sleep apnea (OSA). These studies did not evaluate the benefit of the treatment on the cardiovascular system.

Primary end-point:

To investigate the effects of acupuncture in improving OSA severity among hypertensive patients.

Secondary end-point To investigate the effect of acupuncture in improving the quality of life and sleep assessed by the Short Form 36 (SF-36) questionnaire and Pittsburgh Questionaire (PSQI); To investigate the effect of acupuncture in blood pressure and arterial stiffness

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
Double (Participant, Care Provider)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •5<apnea-hypopnea index (AHI)<30 e/h

排除标准

  • •body mass index > 35 kg/m2
  • •Previous OSA treatment

研究组 & 干预措施

sham acupuncture

Sham Comparator

group will be submitted to placebo electroacupuncture for 20 minutes, two times a week for 5 weeks. Each session lasts about 40 min.

干预措施: acupuncture (Other)

acupuncture

Experimental

group will be submitted to electroacupuncture for 20 minutes, two times a week for 5 weeks. Each session lasts about 40 min.

干预措施: acupuncture (Other)

结局指标

主要结局

Apnea-hypopnea index (AHI)

时间窗: 5 weeks

reduction in AHI

次要结局

  • Quality of life(5 weeks)
  • Sleep quality(5 weeks)
  • Pulse Wave Velocity (PWV)(5 weeks)
  • Blood pressure(5 weeks)

研究者

发起方
University of Pernambuco
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodrigo Pinto Pedrosa

MD, PhD

University of Pernambuco

研究点 (1)

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