Tokyo, July 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062114) titled 'Observational study of smart ring based prediction of Meniere disease attacks' on July 2.

Study Type: Observational

Primary Sponsor: Institute - St Marianna University School of Medicine

Condition: Condition - Meniere disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to prospectively evaluate the association between continuous physiological data obtained from a smart ring and vertigo attack events in patients with definite Meniere disease diagnosed according to the diagnostic criteria of the Japan Society for Equilibrium Research. This study also aims to identify physiological changes that precede vertigo attacks and to explore candidate indicators of the pre-attack phase as a basis for future development of attack prediction algorithms. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients diagnosed with definite Meniere disease according to the diagnostic criteria of the Japan Society for Equilibrium Research 2. Adults aged 20 years or older 3. Patients who have received sufficient explanation about the study and provided written informed consent 4. Patients who are able to wear the smart ring and continuously collect physiological data in daily life 5. Patients who are able to record vertigo attacks using a vertigo diary and complete questionnaires Key exclusion criteria - 1. Patients who have difficulty wearing or continuously using the smart ring, including those with skin disease or abnormality at the wearing site 2. Patients who have difficulty recording vertigo attacks using a vertigo diary or completing questionnaires 3. Patients with severe psychiatric disease or cognitive impairment that makes it difficult to understand the study or obtain informed consent Target Size - 60

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 07 Month 01 Day Date of IRB - 2026 Year 07 Month 01 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071077

Disclaimer: Curated by HT Syndication.