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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036053
Receipt No. R000041051
Scientific Title The standardization of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders: a preliminary study of reliability
Date of disclosure of the study information 2019/03/01
Last modified on 2019/03/01

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Basic information
Public title The standardization of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders: a preliminary study of reliability
Acronym The reliability of 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 preliminary study of reliability
Scientific Title:Acronym The reliability of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders
Region
Japan

Condition
Condition Circadian sleep-wake rhythm disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The examination of the reliability of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders
Basic objectives2 Others
Basic objectives -Others Reliability
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Inter-rater reliability of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders
Key secondary outcomes 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

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 understanding.
2. >= 15 and < 75 years old and having graduated from a junior highschool at the consent
3. With a diagnosis of delayed sleep-wake phase disorder, non-24-hour 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 were judged inappropriate by a researcher in this study for some other reason
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TSUYOSHI KITAJIMA
Organization School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-98 Dengakugakubo,Kutsukake-ch o,Toyoake, Aichi 470-1192,JAPAN
TEL 0562-93-9250
Email tsuyoshi@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name TSUYOSHI KITAJIMA
Organization School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-98 Dengakugakubo,Kutsukake-ch o,Toyoake, Aichi 470-1192,JAPAN
TEL 0562-93-9250
Homepage URL
Email tsuyoshi@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization Japan 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
Address
Tel
Email

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
2019 Year 03 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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a validation study of our original questionnaire.

Management information
Registered date
2019 Year 03 Month 01 Day
Last modified on
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041051

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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