Effect of Easy Sleep Complex Essential Oil Inhalation on Sleep Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-04

Study Completion Date

2022-01-17

Brief Summary

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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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Detailed Description

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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

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Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Aromatherapy with essential oil

Intervention Type OTHER

the aromatherapy by fragrance inhalation

Lavender essential oil

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

Group Type ACTIVE_COMPARATOR

Aromatherapy with essential oil

Intervention Type OTHER

the aromatherapy by fragrance inhalation

Interventions

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Aromatherapy with essential oil

the aromatherapy by fragrance inhalation

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No