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Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders

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ClinicalTrials.gov Identifier: NCT03933553
Recruitment Status : Not yet recruiting
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
Hung Kaung University
Information provided by (Responsible Party):
Chun-pai Yang, MD, 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.

Condition or disease Intervention/treatment Phase
Sleep Disorder Other: Aromatherapy with essential oil Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders
Estimated Study Start Date : May 4, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders

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




Primary Outcome Measures :
  1. Electroencephalogram (EEG) [ Time Frame: 2 days ]
    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. Electrooculograph (EOG) [ Time Frame: 2 days ]
    a record of the difference in electrical charge between the front and back of the eye

  3. Electrocardiogram (ECG) [ Time Frame: 2 days ]
    measure heart rate variability (HRV): change of R-R interval

  4. Electromyogram (EMG) [ Time Frame: 2 days ]
    recording the electrical activity produced by skeletal muscles

  5. Respiratory effort [ Time Frame: 2 days ]
    The amplitude change of chest and abdominal movement

  6. Air flow [ Time Frame: 2 days ]
    The amplitude change of nasal pressure and thermistor

  7. Blood pressure (mmHg) [ Time Frame: 2 days ]
    Systolic and Diastolic blood pressure

  8. Blood oxygen saturation (the fraction of oxygen) [ Time Frame: 2 days ]
    saturated hemoglobin relative to total hemoglobin in the blood

  9. Heart Rate (beats per minute) [ Time Frame: 2 days ]
    Rate of heart beat

  10. The number of sleep gestures during the sleep [ Time Frame: 2 days ]
    Analyzed with video recording overnight


Secondary Outcome Measures :
  1. Concentration of Interleukin-1 [ Time Frame: 2 days ]
    blood test with fasting status

  2. Concentration of Interleukin-6 [ Time Frame: 2 days ]
    blood test with fasting status

  3. Concentration of Interleukin-8 [ Time Frame: 2 days ]
    blood test with fasting status

  4. Concentration of Tumor necrosis factor-alpha [ Time Frame: 2 days ]
    blood test with fasting status

  5. Concentration of Malonaldehyde [ Time Frame: 2 days ]
    Indicator of oxidative stress

  6. Concentration of Total antioxidant capacity [ Time Frame: 2 days ]
    Indicator of oxidative stress



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933553


Contacts
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Contact: Chun-Pai Yang, MD neuralyung@gmail.com neuralyung@gmail.com

Locations
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Taiwan
Kuang Tien General Hospital
Taichung, Taiwan, 433
Sponsors and Collaborators
Kuang Tien General Hospital
Hung Kaung University

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Responsible Party: Chun-pai Yang, MD, Head of Sleep Center, Kuang Tien General Hospital
ClinicalTrials.gov Identifier: NCT03933553     History of Changes
Other Study ID Numbers: I10744
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chun-pai Yang, MD, Kuang Tien General Hospital:
aromatherapy essential oil
Easy Sleep complex essential oil
Lavender essential oil
sleep disorders
Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Disease
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders