UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044683 |
|---|---|
| Receipt number | R000051029 |
| Scientific Title | The standardization of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders: a study of reliability and validity relevant to the measurement of treatment response |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2023/11/04 09:50:43 |
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Basic information
Public title
The standardization of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders: a study of reliability and validity relevant to the measurement of treatment response
Acronym
The measurement of treatment response with the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders
Scientific Title
The standardization of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders: a study of reliability and validity relevant to the measurement of treatment response
Scientific Title:Acronym
The measurement of treatment response with the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders
Region
| Japan |
Condition
Condition
Circadian rhythm sleep-wake disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The examination of the reliability and variability of the Scale for Symptom Severity of Circadian Slee p-Wake Rhythm Disorders, including the measurement of treatment response
Basic objectives2
Others
Basic objectives -Others
Reliability and validity including the measurement of treatment response
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlations between the change of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders and that of CGI-S
Key secondary outcomes
Inter-rater reliability of the Scale f or Symptom Severity of Circadian Sleep-Wake Rhythm Disorders
Internal consistency of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders
Factorial structure of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders
Criterion validity of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders with regards to other questionnaires, DLMO, and actigraphic parameters
Correlations between the change of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders and those of other questionnaires, DLMO, and actigraphic parameters
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who were fully informed and gave written consent voluntarily with sufficient understandi ng.
2. >= 15 and < 75 years old and h aving graduated from a junior highschool at the consent
3. With a diagnosis of delayed sle ep-wake phase disorder, non-24-h our sleep-wake rhythm disorder, or irregular sleep-wake rhythm disorder according to International Classification of Sleep Disorders, 3rd edition(ICSD-3), including patients whose symptoms had remitted after treatment
4.Psychiatric and/or physical comorbidities are allowed
5. No restriction as to the ongoing treatments
Key exclusion criteria
1. Shiftwork disorder or Jet lag disorder according to ICSD-3
2. Those who are judged inappropriate by a researcher in this stu dy for some other reason
Target sample size
50
Research contact person
Name of lead principal investigator
| 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
tsuyoshi@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
Japanese Science and Technology Agency
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
The ethics committee of Fujita Health 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
| 2021 | Year | 07 | 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
| 2021 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 02 | 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
Measurements include the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders (2 Drs), Severity level criteria for delayed sleep phase syndrome (1 Dr), CGI-S (1 Dr), the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders-self administration version (pt), Likert scale (pt), MEQ (pt), MCTQ (pt), sleep diary and actigraphy (pt: >=1 week), DLMO are implemented a t any two points (within a year interval).
Management information
Registered date
| 2021 | Year | 06 | Month | 28 | 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=R000051029
| Research Plan | |
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