Clinical trial NCT03933553: Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders
Official title: Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Keywords: aromatherapy essential oil
Easy Sleep complex essential oil
Lavender essential oil
sleep disorders
Lead sponsor: Kuang Tien General Hospital
Sponsor class: OTHER
Collaborators: name: Hung Kaung University
First posted: 2019-05-01
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Electroencephalogram (EEG)
timeFrame: 2 days
measure: Electrooculograph (EOG)
timeFrame: 2 days
measure: Electrocardiogram (ECG)
timeFrame: 2 days
measure: Electromyogram (EMG)
timeFrame: 2 days
measure: Respiratory effort
timeFrame: 2 days
measure: Air flow
timeFrame: 2 days
measure: Blood pressure (mmHg)
timeFrame: 2 days
measure: Blood oxygen saturation (the fraction of oxygen)
timeFrame: 2 days
measure: Heart Rate (beats per minute)
timeFrame: 2 days
measure: The number of sleep gestures during the sleep
timeFrame: 2 days
Secondary outcomes:
measure: Concentration of Interleukin-1
timeFrame: 2 days
measure: Concentration of Interleukin-6
timeFrame: 2 days
measure: Concentration of Interleukin-8
timeFrame: 2 days
measure: Concentration of Tumor necrosis factor-alpha
timeFrame: 2 days
measure: Concentration of Malonaldehyde
timeFrame: 2 days
measure: Concentration of Total antioxidant capacity
timeFrame: 2 days
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Kuang Tien General Hospital
Study officials:
References: