UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062669 |
|---|---|
| Receipt number | R000071700 |
| Scientific Title | A study of the post-illumination pupil response in circadian rhythm sleep-wake disorders |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/24 16:46:17 |
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Basic information
Public title
A study of the post-illumination pupil response in circadian rhythm sleep-wake disorders
Acronym
A study of the post-illumination pupil response in circadian rhythm sleep-wake disorders
Scientific Title
A study of the post-illumination pupil response in circadian rhythm sleep-wake disorders
Scientific Title:Acronym
A study of the post-illumination pupil response in circadian rhythm sleep-wake disorders
Region
| Japan |
Condition
Condition
circadian rhythm sleep-wake disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the pathophysiology of circadian rhythm sleep-wake disorders, we will assess light sensitivity using the post-illumination pupil response in patients with delayed sleep-wake phase disorder and non-24-hour sleep-wake rhythm disorder and compare the results with those of healthy controls.
Basic objectives2
Others
Basic objectives -Others
Evaluation of light sensitivity using the post-illumination pupil response.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the post-illumination pupil response between patients with circadian rhythm sleep-wake disorders and healthy controls.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Post-illumination pupil response is measured using an electronic pupillometer.
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
| 12 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
<Participants>
1.Patients who provided written informed consent of their own free will after receiving a sufficient explanation of the study and fully understanding its contents.
2.Patients aged 12 years or older and younger than 70 years at the time of consent, who had completed elementary school.
3.Patients diagnosed with delayed sleep-wake phase disorder (DSWPD) or non-24-hour sleep-wake rhythm disorder (N24SWD) according to the ICSD-3 diagnostic criteria.
4.The presence or absence of comorbid psychiatric or physical disorders was not restricted.
5.No restrictions were placed on current treatment.
<Healthy Controls>
1.Individuals who provided written informed consent of their own free will after receiving a sufficient explanation of the study and fully understanding its contents.
2.Individuals aged 12 years or older and younger than 70 years at the time of consent, who had completed elementary school.
3.Individuals without disturbances in their sleep-wake rhythm.
Key exclusion criteria
<Participants>
1.Patients with severe suicidal ideation.
2.Patients judged by the principal investigator or co-investigators to be unsuitable for participation in the study.
<Healthy Controls>
1.Individuals who meet the diagnostic criteria for any sleep disorder or psychiatric disorder according to the ICSD-3 or DSM-5.
2.Individuals currently using psychotropic medications, such as antipsychotics, antidepressants, or hypnotics.
3.Individuals judged by the principal investigator or co-investigators to be unsuitable for participation in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Kitajima |
Organization
Fujita Health University
Division name
Department of Psychiatry
Zip code
4701192
Address
Dengakugakubo,Kutsukake-cho,Toyoake,Aichi,Japan
TEL
0562-93-2170
tsuyoshi@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Marina |
| Middle name | |
| Last name | Hirose |
Organization
Fujita Health University
Division name
Department of Psychiatry
Zip code
4701192
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi,Japan
TEL
0562-93-2170
Homepage URL
mhirose@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethics committee of Fujita Health University
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi,Japan
Tel
0562-93-2865
f-irb@fujita-hu.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 | 09 | Month | 01 | 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 | 08 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 08 | Month | 24 | Day |
Last modified on
| 2026 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071700
