Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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 5.
The subjects are willing to cooperate with the study requirements, examinations and tests, including aromatherapy, polysomnography for two consecutive nights, questionnaire and blood tests.

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Easy sleep complex essential oil	Aromatherapy with essential oil	Aromatherapy for 2 hours starting 10 minutes before sleep with 5 drops of the essential oil diluted in 50ml water
Lavender essential oil	Aromatherapy with essential oil	Aromatherapy for 2 hours starting 10 minutes before sleep with 5 drops of the essential oil diluted in 50ml water

Primary Outcome Measures

Name	Time	Method
Air flow	2 days	The amplitude change of nasal pressure and thermistor
Respiratory effort	2 days	The amplitude change of chest and abdominal movement
Electroencephalogram (EEG)	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).
Electrooculograph (EOG)	2 days	a record of the difference in electrical charge between the front and back of the eye
Electrocardiogram (ECG)	2 days	measure heart rate variability (HRV): change of R-R interval
Electromyogram (EMG)	2 days	recording the electrical activity produced by skeletal muscles
Blood pressure (mmHg)	2 days	Systolic and Diastolic blood pressure
Blood oxygen saturation (the fraction of oxygen)	2 days	saturated hemoglobin relative to total hemoglobin in the blood
Heart Rate (beats per minute)	2 days	Rate of heart beat
The number of sleep gestures during the sleep	2 days	Analyzed with video recording overnight

Secondary Outcome Measures

Name	Time	Method
Concentration of Interleukin-1	2 days	blood test with fasting status
Concentration of Interleukin-6	2 days	blood test with fasting status
Concentration of Interleukin-8	2 days	blood test with fasting status
Concentration of Tumor necrosis factor-alpha	2 days	blood test with fasting status
Concentration of Malonaldehyde	2 days	Indicator of oxidative stress
Concentration of Total antioxidant capacity	2 days	Indicator of oxidative stress