JPRN-jRCTs032210509已完成未知
Exploratory clinical research on therapeutic effect of low-frequency sound stimulation device for obstructive sleep apnea - MARI21001
Fukase Hiroyuki0 个研究点目标入组 60 人开始时间: 2021年12月23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
- 60
研究概览
简要总结
This study is an exploratory evaluation of efficacy and safety when using a low-frequency sound stimulator. While the awakening increased when using the low frequency sound stimulator, the improvement of REI and ODI of the primary endpoints was recognized, and it is considered to be a highly safe device. Although the parameter setting of the low frequency sound stimulator is a matter for consideration, it was a useful result for advancing the development of future equipment.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patient who is able to give a written consent according to an attending physician
- •2) 20 years old or over when obtaining consent
- •3)Patients with suspected OSA in any of the following criteria:
- •i) Housemates often pointed out to habitual loud snoring.
- •ii) Patients have been pointed out multiple times to breath-holding during sleep.
- •iii) Patients who often feel heavy drowsiness during the day, even if they think they have had enough sleep.
排除标准
- •1) Diagnosed with central sleep apnea syndrome (CSAS)
- •2) A cardiac pacemaker in their body
- •3) Concomitant arrhythmia
- •4) Previous myocardial infarction
- •5) The aurally challenged
- •6) BMI (body-mass index) is 32 kg/m^2 or more
- •7) Upper limb prosthesis users
- •8) Pregnancy or Lactation
- •9) Taking drugs affecting sleep and wakefulness
- •10) Uncontrolled blood pressure even when pharmacotherapy (systolic blood pressure overed 160 mmHg or diastolic blood pressure overed 100 mmHg)
- •11) Patients with SAS in active treatment
- •(ex. Continuous Positive Airway Pressure (CPAP) Therapy, using an intraoral device)
- •12) Tobacco smorker (1 pack or more per day)
- •13) Hypersensitive patients
- •14) Patients otherwise whom principal investigator/sub- investigator considered medically ineligible to participate in the study.
研究者
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