Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders

Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders

Sponsors

Lead Sponsor: Kuang Tien General Hospital

Collaborator: Hung Kaung University

Source Kuang Tien General Hospital
Brief 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.

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.

Overall Status Recruiting
Start Date 2019-05-04
Completion Date 2020-12-31
Primary Completion Date 2020-12-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Electroencephalogram (EEG) 2 days
Electrooculograph (EOG) 2 days
Electrocardiogram (ECG) 2 days
Electromyogram (EMG) 2 days
Respiratory effort 2 days
Air flow 2 days
Blood pressure (mmHg) 2 days
Blood oxygen saturation (the fraction of oxygen) 2 days
Heart Rate (beats per minute) 2 days
The number of sleep gestures during the sleep 2 days
Secondary Outcome
Measure Time Frame
Concentration of Interleukin-1 2 days
Concentration of Interleukin-6 2 days
Concentration of Interleukin-8 2 days
Concentration of Tumor necrosis factor-alpha 2 days
Concentration of Malonaldehyde 2 days
Concentration of Total antioxidant capacity 2 days
Enrollment 200
Condition
Intervention

Intervention Type: Other

Intervention Name: Aromatherapy with essential oil

Description: the aromatherapy by fragrance inhalation

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

20 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Chun-Pai Yang, MD

Phone: [email protected]

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Kuang Tien General Hospital Nai-Hwei Wang, MD 886426885599 [email protected] Chun-Pai Yang, MD Principal Investigator
Location Countries

Taiwan

Verification Date

2020-03-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Kuang Tien General Hospital

Investigator Full Name: Chun-pai Yang, MD

Investigator Title: Head of Sleep Center

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Easy sleep complex essential oil

Type: Experimental

Description: Aromatherapy for 2 hours starting 10 minutes before sleep with 5 drops of the essential oil diluted in 50ml water

Label: Lavender essential oil

Type: Active Comparator

Description: Aromatherapy for 2 hours starting 10 minutes before sleep with 5 drops of the essential oil diluted in 50ml water

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

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