UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059154 |
|---|---|
| Receipt number | R000067316 |
| Scientific Title | Evaluation of the Effects of Aroma on Autonomic Nervous Activity and Ophthalmic Parameters in Patients with Glaucoma |
| Date of disclosure of the study information | 2025/10/06 |
| Last modified on | 2025/09/22 11:27:00 |
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Basic information
Public title
Evaluation of the Effects of Aroma on Autonomic Nervous Activity and Ophthalmic Parameters in Patients with Glaucoma
Acronym
Evaluation of the Effects of Aroma on Autonomic Nervous Activity and Ophthalmic Parameters in Patients with Glaucoma
Scientific Title
Evaluation of the Effects of Aroma on Autonomic Nervous Activity and Ophthalmic Parameters in Patients with Glaucoma
Scientific Title:Acronym
Evaluation of the Effects of Aroma on Autonomic Nervous Activity and Ophthalmic Parameters in Patients with Glaucoma
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
he primary objective of this study is to objectively evaluate the effects of essential-oil inhalation on autonomic nervous system activity in patients with glaucoma. Aromatherapy is globally recognized for stress reduction, and oils that enhance parasympathetic activity may help rebalance autonomic function. Glaucoma patients often experience psychological burden from long-term treatment and may have reduced ocular blood flow related to sympathetic overactivity, so adjunctive stress-relief interventions are warranted.
The primary objective of this study is to objectively evaluate the effects of essential-oil inhalation on autonomic nervous system activity in patients with glaucoma. Aromatherapy is globally recognized for stress reduction, and oils that enhance parasympathetic activity may help rebalance autonomic function. Glaucoma patients often experience psychological burden from long-term treatment and may have reduced ocular blood flow related to sympathetic overactivity, so adjunctive stress-relief interventions are warranted.
We will assess physiological responses and potential mechanisms using autonomic indices (e.g., heart-rate variability) and ophthalmologic measures (e.g., ocular blood flow, intraocular pressure). By quantifying pre- and post-intervention changes, we aim to evaluate aromatherapy's potential to reduce stress, improve autonomic function, and contribute to quality-of-life improvements in glaucoma patients.
This study is novel in focusing on an ophthalmic patient population and combining objective autonomic measures with ophthalmologic assessments, whereas prior olfactory research has mainly involved healthy or psychiatric populations.
Basic objectives2
Others
Basic objectives -Others
autonomic nervous system function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Saliva collection (salivary cortisol)
Pittsburgh Sleep Quality Index
State-Trait Anxiety Inventory
Flammer syndrome assessment
Heart rate variability
Nailfold capillary
Ocular blood flow
Intraocular pressure
Blood pressure
Heart rate variability
Cerebral activity
Visual Analog Scale
Essential oil usage and recording
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
essential oil
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Age 40-80 years (inclusive).
(2) Patients with open-angle glaucoma (broad definition) attending the Ophthalmology outpatient clinic at Tohoku University Hospital who have provided written informed consent to participate.
Key exclusion criteria
(1) Individuals who are unable to provide informed consent.
(2) Individuals with olfactory dysfunction that prevents adequate perception of odor stimuli (e.g., chronic rhinosinusitis with nasal obstruction, or neurodegenerative diseases associated with hyposmia such as Parkinson's disease or Alzheimer's disease).
(3) Individuals with hypersensitivity to essential oils (e.g., who experience unpleasant reactions or allergic responses to aromatic oils).
(4) Pregnant or breastfeeding women.
(5) Individuals with a history of disorders or current use of medications affecting cortisol secretion (e.g., adrenal, thyroid, or pituitary disorders, or medications known to alter cortisol levels).
(6) Individuals with a history of symptomatic hypotension (e.g., orthostatic dizziness, syncope, vasovagal episodes).
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasuaki |
| Middle name | |
| Last name | Kamata |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-chou, Aoba-ku, Sendai,Miyagi
TEL
0227177294
yasuaki.kamata.e1@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yasuaki |
| Middle name | |
| Last name | Kamata |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-chou, Aoba-ku, Sendai,Miyagi
TEL
0227177294
Homepage URL
yasuaki.kamata.e1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Menicon Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine Ethics Committee
Address
1-1 Seiryo-chou, Aoba-ku, Sendai,Miyagi
Tel
0227173867
ec-med@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 22 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067316
