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临床试验/NCT04102345
NCT04102345已完成早期 1 期

Lavender vs Zolpidem: Sleep Quality During Diagnostic Polysomnography

HealthPartners Institute1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2019年9月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
58
试验地点
1
主要终点
Sleep Efficiency

研究概览

简要总结

In this pragmatic, clinical study the investigators propose that lavender aromatherapy is comparable to Zolpidem (Ambien) in improving the quality of diagnostic sleep studies.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Age >=18 years
  • In-center diagnostic or split night sleep study (PSG)

排除标准

  • No exclusion criteria

研究组 & 干预措施

Lavender

Experimental

1-2 drops of Lavender (essential oil) in approximately 120 ml of distilled water is added to a diffuser 10 minutes before light out. The diffuser runs for approximately 2 hours before automatically being shut off. A low mist option is used on the diffuser.

干预措施: Lavender Aromatherapy (Other)

Zolpidem

Active Comparator

Pre-prescribed, physician directed use of zolpidem. There is no dose exclusionary criteria for the zolpidem. This study does not have any dose specifications, anyone on zolpidem may be eligible.

干预措施: Zolpidem (Drug)

结局指标

主要结局

Sleep Efficiency

时间窗: 1 day

Percentage of total time in bed actually spent in sleep. It is calculated as sum of Stage N1, Stage N2, Stage N3, and REM sleep, divided by the total time in bed and multiplied by 100. A higher percentage is indicative of more efficient sleep.

次要结局

  • Number of Participants With A Successful Polysomnogram (PSG)(1 day)
  • Wake After Sleep Onset (WASO)(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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