- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07688382
The Effect of Lavender Aromatherapy on Cognitive Function in Older Adults With Mild Cognitive Impairment
2. juli 2026 opdateret af: Yuxin Zhang, China Medical University, China
- To analyze the therapeutic effects of lavender aromatherapy on memory function and overall cognitive function in older adults with Mild Cognitive Impairment (MCI);
- To analyze whether lavender aromatherapy improves executive function, language ability, attention, visuospatial ability, anxiety, depression, quality of life, and sleep in older adults with MCI.
Studieoversigt
Detaljeret beskrivelse
The intervention protocol was established as follows: Based on the elderly participant's usual bedtime, the time of going to bed was recorded.
The participant was instructed to assume a comfortable sleeping position, use the graduated dropper provided with the essential oil bottle to measure 0.15 ml (approximately 3 drops; theoretically, 0.05 ml per drop) of diluted lavender essential oil, and drip it vertically onto the upper center of a cotton pad.
The cotton pad was then pinned to the collar with a safety pin, and the participant was instructed to inhale the scent evenly for 30 minutes.
Afterward, the intervention staff or caregiver will remove the cotton pad.
The intervention will be conducted 5 days a week for 12 weeks.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
70
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yuxin Zhang, Graduate
- Telefonnummer: 18867845231
- E-mail: 18867845231@163.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- The MCI mentioned in this study meets the diagnostic criteria proposed by the *Chinese Expert Consensus on the Diagnosis and Treatment of Alzheimer's Disease-Derived Mild Cognitive Impairment (2021)*: cognitive impairment reported by the patient or an informant, or identified by an experienced clinician; objective evidence of impairment in one or more cognitive domains, with episodic memory impairment being the most common; complex instrumental activities of daily living may be mildly impaired, but the ability to perform basic activities of daily living remains independent; the diagnostic criteria for dementia are not met.
- MoCA-Beijing version scores were adjusted for education level: ≤13 for junior high school education or below, ≤19 for high school education, and ≤24 for university education or above; MMSE score >24; ADL score <23.
- Age between 60 and 79 years.
- Normal olfactory function assessed using the "Sniffin' Sticks" test.
- Ability to communicate normally and complete cognitive assessments.
- Residing in a senior care facility with no plans to leave within the next 12 weeks.
Exclusion Criteria:
- Presence of other conditions known to affect cognitive function, such as psychiatric disorders (e.g., schizophrenia, depression).
- History of asthma or any allergic conditions.
- Use of any prescription medications that may impact cognitive function (including psychotropic drugs and others)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Aromatherapy experimental group
Aromatherapy experimental group : Aromatherapy The aromatherapy intervention protocol is as follows: Based on the elderly participant's usual bedtime, record the time they go to bed; instruct them to assume a comfortable sleeping position; using the graduated dropper provided with the essential oil bottle, dispense 0.15 ml (approximately 3 drops; theoretically, 0.05 ml per drop) of diluted lavender essential oil and drip it vertically onto the upper center of a cotton pad; pin the cotton pad to the collar with a safety pin; and have the participant inhale the scent evenly for 30 minutes.
Afterward, the intervention staff or caregiver will remove the cotton pad.
The intervention will be conducted 5 days a week for 12 weeks.
|
Participants in the intervention group will receive aromatherapy inhalation for 30 minutes per session, five times a week, over a period of 12 week
|
|
Ingen indgriben: Control group
no-treatment control group receiving routine health education only
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Gobal cognitive function
Tidsramme: Week 12
|
Use the Mini-Mental State Examination to assess overall cognitive function.
|
Week 12
|
|
Memory
Tidsramme: Week 12
|
Use the Auditory Verbal Learning Test to assess memory function.
|
Week 12
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Language function
Tidsramme: Week 12
|
Use the Boston Naming Test to assess Language function
|
Week 12
|
|
Executive function
Tidsramme: Week 12
|
Use the TMT-B to assess Executive function
|
Week 12
|
|
Visual space
Tidsramme: Week 12
|
Use the Draw-a-Clock Test to assess Visual space
|
Week 12
|
|
Attention
Tidsramme: Week 12
|
Use the TMT-A to assess Attention
|
Week 12
|
|
Anxiety
Tidsramme: Week 12
|
Use the 15-item Geriatric Depression Scale to assess Anxiety
|
Week 12
|
|
Depression
Tidsramme: Week 12
|
Use the 15-item Geriatric Depression Scale to assess Depression
|
Week 12
|
|
Sleep Quality
Tidsramme: Week 12
|
Use the Pittsburgh Sleep Quality Index to assess Depression
|
Week 12
|
|
Quality of Life assess
Tidsramme: Week 12
|
Use the ShortForm 8 Health Survey Questionnaire to assess Depression
|
Week 12
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Yuxin Zhang, Graduate, China Medical University, China
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. januar 2027
Studieafslutning (Anslået)
2. januar 2027
Datoer for studieregistrering
Først indsendt
2. juli 2026
Først indsendt, der opfyldte QC-kriterier
2. juli 2026
Først opslået (Faktiske)
7. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Lun Shen [2025] No. 237
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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