Sleep DisorderNCT03933553
Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders
A study testing Aromatherapy with essential oil in people with Sleep Disorder, run by Kuang Tien General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- Aromatherapy with essential oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 May 2019to 17 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sleep Disorder
- Being tested
- Aromatherapy with essential oil
- Keywords
- aromatherapy essential oil, Easy Sleep complex essential oil, Lavender essential oil, sleep disorders
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy with essential oilOther
the aromatherapy by fragrance inhalation
| Study group | Role | What they receive |
|---|---|---|
| Easy sleep complex essential oil | Experimental | Aromatherapy for 2 hours starting 10 minutes before sleep with 5 drops of the essential oil diluted in 50ml water Receives: Other: Aromatherapy with essential oil |
| Lavender essential oil | Active comparator | Aromatherapy for 2 hours starting 10 minutes before sleep with 5 drops of the essential oil diluted in 50ml water Receives: Other: Aromatherapy with essential oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 days
Electrooculograph (EOG)
a record of the difference in electrical charge between the front and back of the eye
Measured: 2 days
Electrocardiogram (ECG)
measure heart rate variability (HRV): change of R-R interval
Measured: 2 days
Electromyogram (EMG)
recording the electrical activity produced by skeletal muscles
Measured: 2 days
Respiratory effort
The amplitude change of chest and abdominal movement
Measured: 2 days
Air flow
The amplitude change of nasal pressure and thermistor
Measured: 2 days
Blood pressure (mmHg)
Systolic and Diastolic blood pressure
Measured: 2 days
Blood oxygen saturation (the fraction of oxygen)
saturated hemoglobin relative to total hemoglobin in the blood
Measured: 2 days
Heart Rate (beats per minute)
Rate of heart beat
Measured: 2 days
The number of sleep gestures during the sleep
Analyzed with video recording overnight
Measured: 2 days
Secondary outcomes (6)
Concentration of Interleukin-1
blood test with fasting status
Measured: 2 days
Concentration of Interleukin-6
blood test with fasting status
Measured: 2 days
Concentration of Interleukin-8
blood test with fasting status
Measured: 2 days
Concentration of Tumor necrosis factor-alpha
blood test with fasting status
Measured: 2 days
Concentration of Malonaldehyde
Indicator of oxidative stress
Measured: 2 days
Concentration of Total antioxidant capacity
Indicator of oxidative stress
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start4 May 2019
- Primary completion17 Jan 2022
- Study completion17 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuang Tien General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hung Kaung University
- Responsible party
- Principal investigator, Chun-pai Yang, MD, Kuang Tien General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933553
- Sponsor's protocol ID
- I10744
- Status last verified
- Jun 2022
- First submitted
- 23 Apr 2019
- Last updated
- 23 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37098173
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders
- ClinicalTrials.gov ID
- NCT03933553
- Acronym / sponsor ID
- I10744
- Conditions
- Sleep Disorder
- Keywords
- aromatherapy essential oil, Easy Sleep complex essential oil, Lavender essential oil, sleep disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Kuang Tien General HospitalUniversity, hospital or other
- Collaborators
- Hung Kaung University
- Study start
- 4 May 2019 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Easy sleep complex essential oil | Experimental | Other: Aromatherapy with essential oilAromatherapy for 2 hours starting 10 minutes before sleep with 5 drops of the essential oil diluted in 50ml water |
| Lavender essential oil | Active comparator | Other: Aromatherapy with essential oilAromatherapy for 2 hours starting 10 minutes before sleep with 5 drops of the essential oil diluted in 50ml water |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aromatherapy with essential oilthe aromatherapy by fragrance inhalation | Other | Easy sleep complex essential oil, Lavender essential oil |
Primary outcome
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
6 secondary outcomes
Concentration of Interleukin-1
Time frame: 2 days
Concentration of Interleukin-6
Time frame: 2 days
Concentration of Interleukin-8
Time frame: 2 days
Concentration of Tumor necrosis factor-alpha
Time frame: 2 days
Concentration of Malonaldehyde
Time frame: 2 days
Concentration of Total antioxidant capacity
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Derived from this study: PubMed 37098173Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy with essential oil in people with Sleep Disorder, run by Kuang Tien General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalogram (EEG) (time frame: 2 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03933553, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.