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| Name | Class |
|---|---|
| Hung Kaung University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Easy sleep complex essential oil | Experimental | Aromatherapy for 2 hours starting 10 minutes before sleep with 5 drops of the essential oil diluted in 50ml water |
|
| Lavender essential oil | Active Comparator | Aromatherapy for 2 hours starting 10 minutes before sleep with 5 drops of the essential oil diluted in 50ml water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromatherapy with essential oil | Other | the aromatherapy by fragrance inhalation |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Interleukin-1 | blood test with fasting status | 2 days |
| Concentration of Interleukin-6 | blood test with fasting status |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuang Tien General Hospital | Taichung | 433 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37098173 | Derived | Yang CP, Yang CC, Tsai IJ, Lin TH, Chiou YL, Wang HF, Chang CM, Yih KH. The immediate effects of lavender-based essential oil inhalation on subsequent polysomnography in people with poor sleep quality. J Chin Med Assoc. 2023 Jul 1;86(7):665-671. doi: 10.1097/JCMA.0000000000000932. Epub 2023 Apr 25. |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019341 | Aromatherapy |
| D009822 | Oils, Volatile |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D008517 | Phytotherapy |
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| 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 |
| 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 |
| D001523 | Mental Disorders |
| D026421 |
| Sensory Art Therapies |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D009821 | Oils |
| D008055 | Lipids |