UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048968 |
|---|---|
| Receipt number | R000055683 |
| Scientific Title | A study for variability of attention along the course of circadian rhythm sleep-wake disorders |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2023/11/04 09:42:08 |
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Basic information
Public title
A study for variability of attention along the course of circadian rhythm sleep-wake disorders
Acronym
A study for variability of attention along the course of circadian rhythm sleep-wake disorders
Scientific Title
A study for variability of attention along the course of circadian rhythm sleep-wake disorders
Scientific Title:Acronym
A study for variability of attention along the course of 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
Growing evidence has suggested that human attention or the symptoms of attention deficit hyperactivity disorder (ADHD) may be affected by sleep or circadian rhythm. The aim of this study is to clarify whether these are variable along with the course of circadian rhythm sleep-wake disorders (CRSWDs).
Basic objectives2
Others
Basic objectives -Others
Symptomatology, pathophisiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between the changes of continuous performance test (CPT) and circadian rhythm along with the course of CRSWD
Key secondary outcomes
-The association between the changes of ADHD symptoms and circadian rhythm along with the course of CRSWD
-Diurnal variation of CPT in CRSWD
-The association between CPT and circadian rhythm, sleep duration, depressive mood, sleepiness, and comorbid psychiatric disorders in CRSWD
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
| 15 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Patients with CRSWD (delayed sleep-wake phase disorder and non-24-hour sleep-wake rhythm disorder) according to ICSD-3
-Who are treated at Fujita Health Universit Hospital, Department of Psychiatry (with both inpatient and outpatient treatment)
-There is no restriction as to comorbidities and ongoing treatments
Key exclusion criteria
Patients whom doctors in charge consider inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | NAKAO |
| Middle name | |
| Last name | IWATA |
Organization
Fujita Health University, School of Medicine
Division name
Department of Psychiatry
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, 470-1192, JAPAN
TEL
0562-93-9250
nakao@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | TSUYOSHI |
| Middle name | |
| Last name | KITAJIMA |
Organization
Fujita Health University, School of Medicine
Division name
Department of Psychiatry
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, 470-1192, JAPAN
TEL
0562-93-9250
Homepage URL
tsuyoshi@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 He alth University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, 470-1192, JAPAN
Tel
0562-93-2865
r-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
| 2022 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design:
Prospective, longitudinal, and observational study with naturalistic treatment counrse
Data collection:
-Baseline assessments:
1) The Mini-International Neuropsychiatric Interview(MINI)
2) ADHD screening (e.g., ASRS)
3) ASD screening (e.g., AQ-J)
4) ADHD-RS-IV
5) Beck Depression Inventory (BDI)
6) Chronotype questinnaire (e.g., Horne-Ostberg Morningness-Eveningness Questionnaire)
7) Epworth Sleepiness Score (ESS)
8) Actigraphy (>= 1 week)
9) Sleep diary (>= 1 week)
10) Continuous Performance Test 3 (CPT3) 3 times/1 day (morning, afternoon, evening)
-Follow-up assessments: within 2 years after baseline assessment
4) to 10)
Management information
Registered date
| 2022 | Year | 09 | Month | 20 | Day |
Last modified on
| 2023 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055683
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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