Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders

Sleep Disorder Clinical Trial

Official title:

Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03933553
• Other study ID #: I10744
• Status: Completed
• Phase: N/A
• Start date: May 4, 2019
• Est. completion date: January 17, 2022

Study information

• Verified date: June 2022
• Source: Kuang Tien General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 17, 2022
• Est. primary completion date: January 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

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.

Related Conditions & MeSH terms

• Disease
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Other:
• Aromatherapy with essential oil
the aromatherapy by fragrance inhalation

Locations

Country	Name	City	State
Taiwan	Kuang Tien General Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
Kuang Tien General Hospital	Hung Kaung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Electrooculograph (EOG)	a record of the difference in electrical charge between the front and back of the eye	2 days
Primary	Electrocardiogram (ECG)	measure heart rate variability (HRV): change of R-R interval	2 days
Primary	Electromyogram (EMG)	recording the electrical activity produced by skeletal muscles	2 days
Primary	Respiratory effort	The amplitude change of chest and abdominal movement	2 days
Primary	Air flow	The amplitude change of nasal pressure and thermistor	2 days
Primary	Blood pressure (mmHg)	Systolic and Diastolic blood pressure	2 days
Primary	Blood oxygen saturation (the fraction of oxygen)	saturated hemoglobin relative to total hemoglobin in the blood	2 days
Primary	Heart Rate (beats per minute)	Rate of heart beat	2 days
Primary	The number of sleep gestures during the sleep	Analyzed with video recording overnight	2 days
Secondary	Concentration of Interleukin-1	blood test with fasting status	2 days
Secondary	Concentration of Interleukin-6	blood test with fasting status	2 days
Secondary	Concentration of Interleukin-8	blood test with fasting status	2 days
Secondary	Concentration of Tumor necrosis factor-alpha	blood test with fasting status	2 days
Secondary	Concentration of Malonaldehyde	Indicator of oxidative stress	2 days
Secondary	Concentration of Total antioxidant capacity	Indicator of oxidative stress	2 days