Tokyo, Oct. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059154) titled 'Evaluation of the Effects of Aroma on Autonomic Nervous Activity and Ophthalmic Parameters in Patients with Glaucoma' on Oct. 6.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Tohoku University

Condition: Condition - glaucoma Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: Interventions/Control_1 - essential oil

Eligibility: Age-lower limit - 40 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 Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 25 Day Anticipated trial start date - 2025 Year 10 Month 14 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067316

Disclaimer: Curated by HT Syndication.