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Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders

Primary Purpose

Sleep Disorder

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Aromatherapy with essential oil
Sponsored by
Kuang Tien General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorder focused on measuring aromatherapy essential oil, Easy Sleep complex essential oil, Lavender essential oil, sleep disorders

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kuang Tien General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Easy sleep complex essential oil

Lavender essential oil

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
Electrooculograph (EOG)
a record of the difference in electrical charge between the front and back of the eye
Electrocardiogram (ECG)
measure heart rate variability (HRV): change of R-R interval
Electromyogram (EMG)
recording the electrical activity produced by skeletal muscles
Respiratory effort
The amplitude change of chest and abdominal movement
Air flow
The amplitude change of nasal pressure and thermistor
Blood pressure (mmHg)
Systolic and Diastolic blood pressure
Blood oxygen saturation (the fraction of oxygen)
saturated hemoglobin relative to total hemoglobin in the blood
Heart Rate (beats per minute)
Rate of heart beat
The number of sleep gestures during the sleep
Analyzed with video recording overnight

Secondary Outcome Measures

Concentration of Interleukin-1
blood test with fasting status
Concentration of Interleukin-6
blood test with fasting status
Concentration of Interleukin-8
blood test with fasting status
Concentration of Tumor necrosis factor-alpha
blood test with fasting status
Concentration of Malonaldehyde
Indicator of oxidative stress
Concentration of Total antioxidant capacity
Indicator of oxidative stress

Full Information

First Posted
April 23, 2019
Last Updated
June 22, 2022
Sponsor
Kuang Tien General Hospital
Collaborators
Hung Kaung University
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1. Study Identification

Unique Protocol Identification Number
NCT03933553
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 4, 2019 (Actual)
Primary Completion Date
January 17, 2022 (Actual)
Study Completion Date
January 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuang Tien General Hospital
Collaborators
Hung Kaung University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder
Keywords
aromatherapy essential oil, Easy Sleep complex essential oil, Lavender essential oil, sleep disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Easy sleep complex essential oil
Arm Type
Experimental
Arm Description
Aromatherapy for 2 hours starting 10 minutes before sleep with 5 drops of the essential oil diluted in 50ml water
Arm Title
Lavender essential oil
Arm Type
Active Comparator
Arm Description
Aromatherapy for 2 hours starting 10 minutes before sleep with 5 drops of the essential oil diluted in 50ml water
Intervention Type
Other
Intervention Name(s)
Aromatherapy with essential oil
Intervention Description
the aromatherapy by fragrance inhalation
Primary Outcome Measure Information:
Title
Electroencephalogram (EEG)
Description
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).
Time Frame
2 days
Title
Electrooculograph (EOG)
Description
a record of the difference in electrical charge between the front and back of the eye
Time Frame
2 days
Title
Electrocardiogram (ECG)
Description
measure heart rate variability (HRV): change of R-R interval
Time Frame
2 days
Title
Electromyogram (EMG)
Description
recording the electrical activity produced by skeletal muscles
Time Frame
2 days
Title
Respiratory effort
Description
The amplitude change of chest and abdominal movement
Time Frame
2 days
Title
Air flow
Description
The amplitude change of nasal pressure and thermistor
Time Frame
2 days
Title
Blood pressure (mmHg)
Description
Systolic and Diastolic blood pressure
Time Frame
2 days
Title
Blood oxygen saturation (the fraction of oxygen)
Description
saturated hemoglobin relative to total hemoglobin in the blood
Time Frame
2 days
Title
Heart Rate (beats per minute)
Description
Rate of heart beat
Time Frame
2 days
Title
The number of sleep gestures during the sleep
Description
Analyzed with video recording overnight
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Concentration of Interleukin-1
Description
blood test with fasting status
Time Frame
2 days
Title
Concentration of Interleukin-6
Description
blood test with fasting status
Time Frame
2 days
Title
Concentration of Interleukin-8
Description
blood test with fasting status
Time Frame
2 days
Title
Concentration of Tumor necrosis factor-alpha
Description
blood test with fasting status
Time Frame
2 days
Title
Concentration of Malonaldehyde
Description
Indicator of oxidative stress
Time Frame
2 days
Title
Concentration of Total antioxidant capacity
Description
Indicator of oxidative stress
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Kuang Tien General Hospital
City
Taichung
ZIP/Postal Code
433
Country
Taiwan

12. IPD Sharing Statement

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Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders

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