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临床试验/NCT06247696
NCT06247696已完成不适用

Sweet Scents to Sweet Dreams: Use of Herbal Pillows to Facilitate Sleep and Improve Quality of Life

Duquesne University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024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
入组人数
30
试验地点
1
主要终点
Sleep Function

研究概览

简要总结

The purpose of this study is to determine the effect of herbal pillows on sleep and quality of life in a healthy population using actigraphy, validated questionnaires and daily diary logs. The goal of this study is to improve sleep and quality of life using herbal and Ayurveda/holistic-based botanical pillows.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

  • You must be at least 18 years of age.
  • You must be willing to adhere to a sleep hygiene protocol (e.g., 10pm-midnight-6-8am) for 2 weeks without interruption in the comfort of your home.
  • You must be willing to wear a watch that monitors your sleep and light as well as a sleep mask for two consecutive weeks.
  • During the testing period, you must be willing to refrain from alcohol and anything that can affect mood and sleep.
  • You must allow for the placement of an herbal pillow next to your head while sleeping for one week during testing.
  • You must be willing to fill out short sleep logs during the 2 weeks of testing.
  • You must also be willing to come to the study location on 3 occasions over a 2 week period.

排除标准

  • Males or females with any condition that prevents adequate inhalation of botanical pillows [e.g., Chronic Obstructive Pulmonary Disease (COPD), use of a Continuous Positive Airway Pressure (CPAP), deviated septum, etc].
  • Males or females on mood altering substances prescription (e.g., anti-depressants, anxiolytics, Ritalin, Adderall, anti-convulsants; opioids, etc), non-prescription/over-the-counter (OTC) drugs/herbal/natural products [(e.g., tetrahydrocannabinol (THC)-containing compounds, melatonin, St. John's Wort, lavender capsules, essential oils, perfume-containing products, etc].
  • Any environmental, physical condition or pathology that can significantly impact on sleep and prevent an approximate 10pm-midnight-6-8am sleep rhythm (e.g., shift work, studying/exams, rotations, insomnia, new parents, nocturia, restless leg syndrome, chronic pain, etc).
  • Any medications that can influence sleep [(e.g., use of beta blockers; anti-histamines; dexamethasone; angiotensin converting enzyme inhibitor (ACEI); nicotine products, alpha blockers]
  • Chemical sensitivities
  • Allergies
  • Pregnancy.

研究组 & 干预措施

Control Pillow

Active Comparator

干预措施: Herbal Pillows (Other)

Vata Pillow

Experimental

干预措施: Herbal Pillows (Other)

Placebo Pillow

Placebo Comparator

干预措施: Herbal Pillows (Other)

Pitta Pillow

Experimental

干预措施: Herbal Pillows (Other)

Kapha Pillow

Experimental

干预措施: Herbal Pillows (Other)

结局指标

主要结局

Sleep Function

时间窗: 2 weeks

Assessments of rest/activity rhythms by wrist actigraphy

次要结局

  • Subject-reported effects on stress(2 weeks)
  • Subject-reported effects on quality of life(2 weeks)
  • Subject-reported effects on depression(2 weeks)
  • Subject-reported effects on sleep(2 weeks)
  • Ayurvedic assessments of doshas(2 weeks)
  • Subject-reported effects on anxiety(2 weeks)

研究者

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

Paula Witt-Enderby

Professor of Pharmacology

Duquesne University

研究点 (1)

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