Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders

Conditions
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Sleep Disorder

Intervention / Treatment
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* Other: Aromatherapy with essential oil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Easy sleep complex essential oil<br>Aromatherapy for 2 hours starting 10 minutes before sleep with 5 drops of the essential oil diluted in 50ml water | Other: Aromatherapy with essential oil<br>* the aromatherapy by fragrance inhalation<br>|
| Active Comparator: Lavender essential oil<br>Aromatherapy for 2 hours starting 10 minutes before sleep with 5 drops of the essential oil diluted in 50ml water | Other: Aromatherapy with essential oil<br>* the aromatherapy by fragrance inhalation<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Interleukin-1 | blood test with fasting status | 2 days | 
| Concentration of Interleukin-6 | blood test with fasting status | 2 days | 
| Concentration of Interleukin-8 | blood test with fasting status | 2 days | 
| Concentration of Tumor necrosis factor-alpha | blood test with fasting status | 2 days | 
| Concentration of Malonaldehyde | Indicator of oxidative stress | 2 days | 
| Concentration of Total antioxidant capacity | Indicator of oxidative stress | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aromatherapy essential oil, Easy Sleep complex essential oil, Lavender essential oil, sleep disorders