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出境医 / 临床实验 / Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders

Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders

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.

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.
Study Design
Layout table for study information
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
Actual Study Start Date : May 4, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Chun-Pai Yang, MD neuralyung@gmail.com neuralyung@gmail.com

Locations
Layout table for location information
Taiwan
Kuang Tien General Hospital Recruiting
Taichung, Taiwan, 433
Contact: Nai-Hwei Wang, MD    886426885599    fengcheese@gmail.com   
Principal Investigator: Chun-Pai Yang, MD         
Sponsors and Collaborators
Kuang Tien General Hospital
Hung Kaung University
Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE May 1, 2019
Last Update Posted Date March 31, 2020
Actual Study Start Date  ICMJE May 4, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2019)
  • 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).
  • Electrooculograph (EOG) [ Time Frame: 2 days ]
    a record of the difference in electrical charge between the front and back of the eye
  • Electrocardiogram (ECG) [ Time Frame: 2 days ]
    measure heart rate variability (HRV): change of R-R interval
  • Electromyogram (EMG) [ Time Frame: 2 days ]
    recording the electrical activity produced by skeletal muscles
  • Respiratory effort [ Time Frame: 2 days ]
    The amplitude change of chest and abdominal movement
  • Air flow [ Time Frame: 2 days ]
    The amplitude change of nasal pressure and thermistor
  • Blood pressure (mmHg) [ Time Frame: 2 days ]
    Systolic and Diastolic blood pressure
  • Blood oxygen saturation (the fraction of oxygen) [ Time Frame: 2 days ]
    saturated hemoglobin relative to total hemoglobin in the blood
  • Heart Rate (beats per minute) [ Time Frame: 2 days ]
    Rate of heart beat
  • The number of sleep gestures during the sleep [ Time Frame: 2 days ]
    Analyzed with video recording overnight
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2019)
  • Concentration of Interleukin-1 [ Time Frame: 2 days ]
    blood test with fasting status
  • Concentration of Interleukin-6 [ Time Frame: 2 days ]
    blood test with fasting status
  • Concentration of Interleukin-8 [ Time Frame: 2 days ]
    blood test with fasting status
  • Concentration of Tumor necrosis factor-alpha [ Time Frame: 2 days ]
    blood test with fasting status
  • Concentration of Malonaldehyde [ Time Frame: 2 days ]
    Indicator of oxidative stress
  • Concentration of Total antioxidant capacity [ Time Frame: 2 days ]
    Indicator of oxidative stress
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders
Official Title  ICMJE Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Sleep Disorder
Intervention  ICMJE Other: Aromatherapy with essential oil
the aromatherapy by fragrance inhalation
Study Arms  ICMJE
  • 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
    Intervention: Other: Aromatherapy with essential oil
  • 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
    Intervention: Other: Aromatherapy with essential oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 28, 2019) 		200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chun-Pai Yang, MD neuralyung@gmail.com neuralyung@gmail.com
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03933553
Other Study ID Numbers  ICMJE I10744
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chun-pai Yang, MD, Kuang Tien General Hospital
Study Sponsor  ICMJE Kuang Tien General Hospital
Collaborators  ICMJE Hung Kaung University
Investigators  ICMJE Not Provided
PRS Account Kuang Tien General Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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