NCT06247696已完成不适用
Sweet Scents to Sweet Dreams: Use of Herbal Pillows to Facilitate Sleep and Improve Quality of Life
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
- 是
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
Paula Witt-Enderby
Professor of Pharmacology
Duquesne University
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Smart Pillows for Enhancing Sleep QualitySnoringObstructive Sleep ApneaNCT06594627Indiana University24
已完成
不适用
Evaluation of an Herbal Extract on Sleep ParametersSleep Onset LatencyNCT05829902Aventure AB52
招募中
不适用
The Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff SyndromeRotator Cuff InjuriesNCT05011331Rhode Island Hospital80
尚未招募
不适用
The Effect of Aromatherapy on Sleep and Cognitive Level in the ElderlyCognitive ImpairmentInsomniaElderlyNCT06208800Medipol University60
终止
不适用
Lavender Aromatherapy for Sleep in Hospitalized Adult PatientsSleepHospitalizationNCT04648215Northwell Health108
