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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
53
the aromatherapy by fragrance inhalation
Kuang Tien General Hospital
Taichung, Taiwan
Electroencephalogram (EEG)
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).
Time frame: 2 days
Electrooculograph (EOG)
a record of the difference in electrical charge between the front and back of the eye
Time frame: 2 days
Electrocardiogram (ECG)
measure heart rate variability (HRV): change of R-R interval
Time frame: 2 days
Electromyogram (EMG)
recording the electrical activity produced by skeletal muscles
Time frame: 2 days
Respiratory effort
The amplitude change of chest and abdominal movement
Time frame: 2 days
Air flow
The amplitude change of nasal pressure and thermistor
Time frame: 2 days
Blood pressure (mmHg)
Systolic and Diastolic blood pressure
Time frame: 2 days
Blood oxygen saturation (the fraction of oxygen)
saturated hemoglobin relative to total hemoglobin in the blood
Time frame: 2 days
Heart Rate (beats per minute)
Rate of heart beat
Time frame: 2 days
The number of sleep gestures during the sleep
Analyzed with video recording overnight
Time frame: 2 days
Concentration of Interleukin-1
blood test with fasting status
Time frame: 2 days
Concentration of Interleukin-6
blood test with fasting status
Time frame: 2 days
Concentration of Interleukin-8
blood test with fasting status
Time frame: 2 days
Concentration of Tumor necrosis factor-alpha
blood test with fasting status
Time frame: 2 days
Concentration of Malonaldehyde
Indicator of oxidative stress
Time frame: 2 days
Concentration of Total antioxidant capacity
Indicator of oxidative stress
Time frame: 2 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.