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Completed

NCT Number: NCT03933553

Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuang Tien General Hospital

Taichung, 433, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aromatherapy with essential oil

Other

the aromatherapy by fragrance inhalation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kuang Tien General Hospital

Other

Collaborators

  • Hung Kaung University

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 1, 2019
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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