UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062114 |
|---|---|
| Receipt number | R000071077 |
| Scientific Title | Prospective multicenter observational study to establish a basis for predicting Meniere disease attacks using a smart ring |
| Date of disclosure of the study information | 2026/07/02 |
| Last modified on | 2026/07/02 08:14:40 |
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Basic information
Public title
Observational study of smart ring based prediction of Meniere disease attacks
Acronym
Smart Ring Meniere Disease Study
Scientific Title
Prospective multicenter observational study to establish a basis for predicting Meniere disease attacks using a smart ring
Scientific Title:Acronym
SR-MD study
Region
| Japan |
Condition
Condition
Meniere disease
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Exploratory study
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in smart ring derived physiological indices among three time points: the day before a vertigo attack, the day of the vertigo attack, and the third day after resolution of the vertigo attack as a representative remission day. Physiological indices include heart rate, heart rate variability, skin temperature, activity measures, and sleep related indices. The observation period is 3 months from enrollment for each participant.
Key secondary outcomes
1. Association between smart ring derived physiological indices and Dizziness Handicap Inventory, Pittsburgh Sleep Quality Index, and Epworth Sleepiness Scale.
2. Patterns of changes in smart ring derived physiological indices according to severity classifications based on audiological and vestibular function test results.
3. Association between smart ring derived physiological indices and the presence, timing, and severity of vertigo attacks recorded in a vertigo diary.
4. Smart ring wearing status and data acquisition status during the observation period.
Assessment time points include enrollment, outpatient visits during the observation period, and the end of the 3 month observation period.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 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 sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Sasano |
Organization
St Marianna University School of Medicine
Division name
Department of Otorhinolaryngology
Zip code
2168511
Address
2 16 1 Sugao Miyamae ku Kawasaki Kanagawa 2168511 Japan
TEL
0449778111
yoshi.sasa330@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumihiro |
| Middle name | |
| Last name | Mochizuki |
Organization
St Marianna University School of Medicine
Division name
Department of Otorhinolaryngology
Zip code
2168511
Address
2 16 1 Sugao Miyamae ku Kawasaki Kanagawa 2168511 Japan
TEL
0449778111
Homepage URL
fumihiro0105@marianna-u.ac.jp
Sponsor or person
Institute
St Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Life Ethics Committee Clinical Trial Review Board St Marianna University School of Medicine
Address
2 16 1 Sugao Miyamae ku Kawasaki Kanagawa 2168511 Japan
Tel
0449778111
k-sienbu.mail@marianna-u.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
| 2026 | Year | 07 | Month | 02 | 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
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2026 | Year | 07 | Month | 02 | Day |
Last modified on
| 2026 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071077
