- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07586761
The Effects of Lemon Essential Oil Inhalation on Attention in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Lemon Essential Oil Inhalation Improves Sustained Attention in Children With Attention-Deficit/Hyperactivity Disorder: A Placebo-Controlled Trial
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
This randomized, placebo-controlled, single-blind clinical trial investigates the acute effects of lemon essential oil (LEO) inhalation on sustained attention and visual memory in children with attention-deficit/hyperactivity disorder (ADHD). Essential oils, particularly those rich in monoterpenes such as limonene, have demonstrated neuroactive properties through cholinergic modulation and limbic-prefrontal engagement via the olfactory pathway.
Fifty-two children aged 9-16 years, newly diagnosed with ADHD and not receiving any pharmacological treatment, were randomized to either the LEO group or the placebo group. Participants in the LEO group inhaled 5 drops of 100% pure Citrus limon essential oil via a cotton pad for five minutes prior to cognitive testing. The placebo group received an identical application with odorless distilled water.
Cognitive performance was assessed at baseline and 30 days later using the D2 Attention Test (primary outcome) and the Benton Visual Memory Test (secondary outcome). The entire intervention was conducted under standardized conditions, with blinded outcome assessment and strict adherence to procedural fidelity.
This study is the first to evaluate the short-term cognitive effects of lemon essential oil inhalation in children with clinical ADHD and aims to provide evidence for potential non-pharmacological support strategies.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Istanbul, Турция (Туркие)
- Basaksehir Çam Ve Sakura City Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Children aged 9 to 16 years
- Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) based on DSM-5 criteria
- Medication-naive (not currently using or previously treated with pharmacological agents for ADHD)
- No chronic medical or psychiatric comorbidities
- Capable of completing standardized cognitive assessments (e.g., D2 Attention Test, Benton Visual Memory Test)
- Written informed consent obtained from a parent or legal guardian
- Written assent obtained from the child
Exclusion Criteria:
- Lack of written parental consent or child assent
- Inability to comply with the study protocol (e.g., refusal to complete cognitive testing or intervention procedure)
- Current or prior use of ADHD medication
- Presence of moderate-to-severe ADHD symptoms requiring immediate pharmacological treatment (based on AACAP 2020 and NICE 2019 guidelines)
- Presence of any chronic medical or psychiatric comorbid condition
- Diagnosis not confirmed by a board-certified child and adolescent psychiatrist
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Lemon Essential Oil Inhalation (LEO)
Participants in this arm received a single-session inhalation of 100% pure lemon essential oil (Citrus limon) via a sterile cotton pad.
Five drops of essential oil were applied to the pad, which was held approximately 5 cm from the participant's nose.
The child inhaled the scent for 5 minutes under supervision in a clinical setting.
Neuropsychological testing (D2 Attention Test and Benton Visual Memory Test) followed immediately after inhalation.
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This intervention consists of a single-session, short-term olfactory exposure to 100% pure lemon essential oil (Citrus limon, ISO 9235 compliant, GC-MS confirmed composition: limonene 67.2%, β-pinene 12.3%, γ-terpinene 9.8%).
Five drops were applied to a sterile cotton pad and held approximately 5 cm from the participant's nose.
Participants inhaled the aroma for 5 minutes under direct supervision in a quiet, odor-free clinical setting.
This intervention was administered immediately prior to standardized neuropsychological assessments measuring attention and visual memory.
No ingestion or topical application occurred.
Другие имена:
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Плацебо Компаратор: Placebo Inhalation (Distilled Water)
Participants in this arm received a single-session inhalation of distilled water as placebo.
Five drops of distilled water were applied to a sterile cotton pad, which was held approximately 5 cm from the participant's nose.
The child inhaled the scentless solution for 5 minutes under supervision.
Neuropsychological testing (D2 Attention Test and Benton Visual Memory Test) followed immediately after inhalation.
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The placebo condition involved the same protocol as the intervention group, using five drops of distilled water applied to a sterile cotton pad.
The pad was held approximately 5 cm from the participant's nose, and inhalation lasted for 5 minutes.
The procedure was designed to mimic the intervention without olfactory stimulation, ensuring consistency in timing, setting, and administration method.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in D2 Attention Test Total Performance Score (TN-E)
Временное ограничение: Baseline and Day 30 (after intervention)
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The D2 Attention Test evaluates sustained attention and concentration performance.
The TN-E (Total Number of Correct Items minus Errors) score reflects attentional capacity.
A higher post-intervention TN-E score indicates improved attention.
The difference between baseline and Day 30 scores will be compared between the lemon essential oil group and placebo group.
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Baseline and Day 30 (after intervention)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Benton Visual Retention Test (BVRT) Score
Временное ограничение: Baseline and Day 30 (after intervention)
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The Benton Visual Retention Test assesses visual memory and visuospatial construction skills.
Scores range based on correct reproductions of geometric figures.
The change in BVRT scores from baseline to Day 30 will be analyzed to assess the impact of lemon essential oil inhalation versus placebo.
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Baseline and Day 30 (after intervention)
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 10.06.2021-21
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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