JPRN-jRCT1061220100招募中2 期
An open-label, randomized, multicenter, exploratory clinical trial to evaluate the efficacy on sleep during repeated exposure to lavender in the elderly subjects
Iwata Masaaki0 个研究点目标入组 12 人开始时间: 2023年2月28日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
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
- 年龄范围
- >= 65age old 至 ot applicable（—）
- 性别
- Male
入选标准
- •1) Japanese male over 65 years old
- •2) Subjects who are judged health by investigator screening test
- •3) Subjects who sleep at night and have regular sleep every day (stable bedtime and wake-up time)
- •4) Subjects who took an average of 15 minutes or more to fall asleep after deciding to sleep in the past month
排除标准
- •1) Subjects with hypersensitivity to the scent of lavender
- •2) Subjects who checked Those who answered that they could not accept staying in a room filled with this scent for a long time in the survey on scent preference at screening
- •3) Subjects with dysosmia or allergic rhinitis
- •4) Subjects with cognitive impairment
- •5) Subjects with a history of insomnia or other mental disease
- •6) Subjects with drug addicts or alcoholics
- •7) Subjects with serious disease
- •8) Subjects who drink excessively or who cannot keep alcohol abstinence during the study period
- •9) Subjects who have a history of smoking within 4 months before enrollment
- •10) Subjects who are aware of snoring or have been pointed out by their family about snoring
- •11) Subjects with hypersensitivity to alcohol disinfection
- •12) Subjects who had a positive with immune serological test at screening
- •13) Subjects who cannot agree to refrain from excessive activity during the study period
- •14) Subjects who participated in other clinical trials or clinical research within 3 months before registration and used unapproved or uninsured drugs
研究者
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