Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders
1 other identifier
interventional
53
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2019
CompletedFirst Posted
Study publicly available on registry
May 1, 2019
CompletedStudy Start
First participant enrolled
May 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2022
CompletedJune 23, 2022
June 1, 2022
2.7 years
April 23, 2019
June 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Easy sleep complex essential oil
EXPERIMENTALAromatherapy for 2 hours starting 10 minutes before sleep with 5 drops of the essential oil diluted in 50ml water
Lavender essential oil
ACTIVE COMPARATORAromatherapy for 2 hours starting 10 minutes before sleep with 5 drops of the essential oil diluted in 50ml water
Interventions
the aromatherapy by fragrance inhalation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kuang Tien General Hospitallead
- Hung Kaung Universitycollaborator
Study Sites (1)
Kuang Tien General Hospital
Taichung, 433, Taiwan
Related Publications (1)
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.
PMID: 37098173DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Sleep Center
Study Record Dates
First Submitted
April 23, 2019
First Posted
May 1, 2019
Study Start
May 4, 2019
Primary Completion
January 17, 2022
Study Completion
January 17, 2022
Last Updated
June 23, 2022
Record last verified: 2022-06