UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063397 |
|---|---|
| Receipt number | R000072563 |
| Scientific Title | Evaluation of the utility of pupillary oscillation as an objective indicator of alertness |
| Date of disclosure of the study information | 2026/10/26 |
| Last modified on | 2026/10/24 15:48:25 |
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Basic information
Public title
Evaluation of the utility of pupillary oscillation as an objective indicator of alertness
Acronym
Evaluation of the utility of pupillary oscillation as an objective indicator of alertness
Scientific Title
Evaluation of the utility of pupillary oscillation as an objective indicator of alertness
Scientific Title:Acronym
Evaluation of the utility of pupillary oscillation as an objective indicator of alertness
Region
| Japan |
Condition
Condition
adults
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the association between pupillary oscillation recorded during the Psychomotor Vigilance Test (PVT) and PVT performance in adults, and to determine whether pupillary oscillation can serve as an objective indicator of alertness.
Basic objectives2
Others
Basic objectives -Others
Exploratory evaluation of the utility of pupillary oscillation as an objective indicator of alertness.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pupillary oscillation during the Psychomotor Vigilance Test (PVT) and PVT performance
Key secondary outcomes
Subjective sleep assessments obtained using questionnaires at the on-site assessment.
Subjective fatigue assessed using a visual analogue scale at the on-site assessment.
Heart rate variability indices of autonomic function recorded during the 15-minute PVT.
Physical activity and sleep indices measured over a total of seven days under daily living conditions.
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)Adults aged 18 years or older at the time of informed consent.
2)Individuals who can visit the study site.
3)Individuals who voluntarily provide written informed consent to participate in the study.
4)Individuals who can cooperate with physical activity and sleep monitoring using monitoring devices under daily living conditions.
Key exclusion criteria
1)Individuals with ocular diseases, iris abnormalities, or other conditions that interfere with accurate pupil measurements.
2)Individuals who have difficulty recognizing the visual stimuli or performing the PVT because of impaired visual function or other reasons.
3)Individuals in whom heart rate variability cannot be appropriately measured or analyzed because of a pacemaker or other conditions.
4)Individuals who have difficulty undergoing physical activity and sleep monitoring using monitoring devices under daily living conditions.
5)Individuals taking hypnotics, psychotropic medications, or other medications that may affect sleep, alertness, or pupillary responses.
Target sample size
50
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
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
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
| 2026 | Year | 10 | Month | 26 | 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
| 2026 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 09 | 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
This prospective cross-sectional observational study will include 50 adults aged 18 years or older. Participants will be recruited from ophthalmology outpatients at Tohoku University Hospital and through public recruitment, including university notices, email, and health promotion events. Physical activity and sleep will be monitored for a total of seven days under daily living conditions. During the on-site assessment, pupil diameter and heart rate variability will be continuously recorded during a 15-minute Psychomotor Vigilance Test (PVT). The association between pupillary oscillation and PVT performance will be examined. Exploratory analyses will also examine associations of pupillary oscillation with subjective sleep assessments, subjective fatigue, autonomic function, and physical activity and sleep indices.
Management information
Registered date
| 2026 | Year | 10 | Month | 24 | Day |
Last modified on
| 2026 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072563
