Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Electroencephalogram (EEG)
研究概览
简要总结
Sleep disorders affect human health tremendously. It has been reported that aromatherapy by fragrance inhalation can be used as an adjuvant therapy to modulate parasympathetic nervous activity for relieving stress and mood, and promoting sleep quality. Many researches confirmed that lavender essential oil can be used as an adjuvant therapy for sleep disorders. It can effectively relieve stress and modulate physical and mental status. However, many studies about aromatherapy lack sleep detection instruments to objectively confirm their effects on sleep physiology. Therefore, this study adopts Easy sleep complex essential oil as the experimental group. The lavender essential oil containing orange, petitgrain, rose, lavender, rosewood, ho wood, amyris essential oil and lavender oil is chosen as control group. The subjects will be randomly assigned to one of the two groups. The efficacy results will be evaluated and compared between the two groups. The investigators expect that aromatherapy by fragrance inhalation with Easy sleep complex essential oil will improve sleep quality more effectively than lavender essential oil.
详细描述
A Randomized, Single-blind, Active-Controlled Trial to Evaluate the aromatherapy by fragrance inhalation using Easy sleep complex essential oil in patients with sleep disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects who signs the informed consent form approved by the Institutional Review Board.
- •Adult between the ages of 20-65 with the ability to communicate and describe symptoms.
- •The subjects has sleep disorders that last for at least three months and more than three nights per week.
- •Pittsburgh Sleep Quality Index(PSQI) score greater than
- •The subjects are willing to cooperate with the study requirements, examinations and tests, including aromatherapy, polysomnography for two consecutive nights, questionnaire and blood tests.
排除标准
- •The patients with abnormal olfactory system such as brain injury, acute or chronic sinusitis, and the history of nasal surgery.
- •Patients who are currently taking sedatives or stimulant medicine or food such as coffee or refresh drink.
- •Patients with a known history of allergy to aromatherapy or asthma.
- •Patients has severe cardiovascular or pulmonary disease (e.g., cardiac failure or lung failure), or has cancer or other critical illness (e.g., renal dialysis).
- •Pregnant or breastfeeding women.
结局指标
主要结局
Electroencephalogram (EEG)
时间窗: 2 days
measure the alpha wave(8-14Hz), Vertex sharp wave(4-7Hz), K complex (negative- positive sharp component area), Spindle(7-14Hz for at least 0.5 sec), theta wave(4-7Hz), and delta wave(0.5-3Hz, amplitude\>75uV).
Respiratory effort
时间窗: 2 days
The amplitude change of chest and abdominal movement
Air flow
时间窗: 2 days
The amplitude change of nasal pressure and thermistor
Electrooculograph (EOG)
时间窗: 2 days
a record of the difference in electrical charge between the front and back of the eye
Electrocardiogram (ECG)
时间窗: 2 days
measure heart rate variability (HRV): change of R-R interval
Electromyogram (EMG)
时间窗: 2 days
recording the electrical activity produced by skeletal muscles
Blood pressure (mmHg)
时间窗: 2 days
Systolic and Diastolic blood pressure
Blood oxygen saturation (the fraction of oxygen)
时间窗: 2 days
saturated hemoglobin relative to total hemoglobin in the blood
Heart Rate (beats per minute)
时间窗: 2 days
Rate of heart beat
The number of sleep gestures during the sleep
时间窗: 2 days
Analyzed with video recording overnight
次要结局
- Concentration of Interleukin-1(2 days)
- Concentration of Interleukin-6(2 days)
- Concentration of Interleukin-8(2 days)
- Concentration of Tumor necrosis factor-alpha(2 days)
- Concentration of Malonaldehyde(2 days)
- Concentration of Total antioxidant capacity(2 days)
研究者
Chun-pai Yang, MD
Head of Sleep Center
Kuang Tien General Hospital