UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016502 |
|---|---|
| Receipt number | R000019162 |
| Scientific Title | A randomized controlled trial of the effect of sleep health program in community. |
| Date of disclosure of the study information | 2015/02/10 |
| Last modified on | 2018/02/13 00:27:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A randomized controlled trial of the effect of sleep health program in community.
Acronym
A randomized controlled trial of the effect of sleep health program in community.
Scientific Title
A randomized controlled trial of the effect of sleep health program in community.
Scientific Title:Acronym
A randomized controlled trial of the effect of sleep health program in community.
Region
| Japan |
Condition
Condition
Subjective difficulties of sleep
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose in this study is to evaluate the effectiveness of sleep health program consisted of sleep hygiene and E-mail program by using randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Insomnia Severity Index
Key secondary outcomes
Beck Depression Inventory
Dysfunctional. Beliefs and Attitudes about Sleep scale
Sleep efficiency (Sleep diary)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Lecture of sleep hygiene
E-mail delivered brief behavioral therapy for insomnia (4 weeks)
Interventions/Control_2
Lecture of sleep hygiene
E-mail delivered breathing training(4 weeks)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
People with subjective sleep problem.
Key exclusion criteria
Individuals with who have histories of substance abuse, active suicidality, severe mental and physical condition and organic sleep disorders(restless legs syndrome and sleep apnea, etc.).
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuo Ishimura |
Organization
Tokyoseitoku University
Division name
Graduate School of Psychology
Zip code
Address
23-2, Oji 3chome, Kita-ku, Tokyo, 114-0002 Japan
TEL
03-3927-4116
i-ishimura@tsu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Asano |
Organization
Graduate School of Medicine, Chiba University
Division name
Research Center for Child Mental Development
Zip code
Address
1-8-1, inohana, Chuo-ku, Chiba city
TEL
043-226-2975
Homepage URL
kenichi.asano1225@gmail.com
Sponsor or person
Institute
Tokyoseitoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
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
| 2015 | Year | 02 | Month | 10 | 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
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 10 | Day |
Last modified on
| 2018 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019162
