Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disorder
• Intervention / Treatment: Other: Aromatherapy with 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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 433
    • Kuang Tien General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Easy sleep complex essential oil; 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; the aromatherapy by fragrance inhalation
Active Comparator: Lavender essential oil; 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; the aromatherapy by fragrance inhalation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kuang Tien General Hospital
• Collaborators: Hung Kaung University

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2019
• Primary Completion (Actual): January 17, 2022
• Study Completion (Actual): January 17, 2022

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 28, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: sleep disorders; Lavender essential oil; aromatherapy essential oil; Easy Sleep complex essential oil
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: I10744

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No