UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016157 |
|---|---|
| Receipt number | R000018568 |
| Scientific Title | Survey on the impact of hypnotic usage in patients with chronic insomnia |
| Date of disclosure of the study information | 2015/01/08 |
| Last modified on | 2017/01/10 16:49:22 |
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Basic information
Public title
Survey on the impact of hypnotic usage in patients with chronic insomnia
Acronym
Survey on the impact of hypnotic usage
Scientific Title
Survey on the impact of hypnotic usage in patients with chronic insomnia
Scientific Title:Acronym
Survey on the impact of hypnotic usage
Region
| Japan |
Condition
Condition
insomnia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate clinical characteristics of insomnia patients, health/insomnia related QoL, and dependence and withdrawal symptoms of hypnotics through cross-sectional survey.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between clinical descriptive variables and treatment outcome.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
hypnotic withdrawal scale, QOL-I (Quality of Life Scale for Insomnia)
Key secondary outcomes
Athens Insomnia Scale, Insomnia Severity Index, HyperArousal Scale, modified version of Clinical Global Impression (entire life, dependency, withdrawal), Ford Insomnia Response to Stress Test, Sheehan Disability Scale, Short-Form 8-item health Survey, Benzodiazepine Dependence Self-Report Questionnaire, Clinical Institute Withdrawal Assessment for Benzodiazepines
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 20-year-old or older outpatients having insomnia
2)meeting the diagnostic criteria for "chronic insomnia disorder" of the International Classification of Sleep Disorders (ICSD third edition: AASM, 2014)
3) taking hypnotic medications for at least 4 weeks
Key exclusion criteria
1) unable to read the description document of the present study, those who cannot understand the purpose of study
2) unable to answer by oneself or no consent capacity for his or her mental and physical symptoms
3) to be judged inappropriate/unsuitable to this research by attending physician
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi INOUE |
Organization
Tokyo Medical University
Division name
Department of Somnology
Zip code
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-3351-6141
inoue@somnology.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mina KOBAYASHI |
Organization
Neuropsychiatric Research Institute
Division name
Japan Somnology Center
Zip code
Address
1-24-10 Yoyogi, Shibuya-ku, Tokyo, Japan
TEL
03-3374-2016
Homepage URL
kobayashi@somnology.com
Sponsor or person
Institute
Neuropsychiatric Research Institute
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Tokyo Women's Medical University, Jikei university school of medicine, Akita University, Hiroshima University, National Center of Neurology and Psychiatry
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
睡眠総合ケアクリニック代々木(東京都)，国立精神・神経医療研究センター(東京都)，東京女子医科大学(東京都)，東京慈恵会医科大学(東京都)，秋田大学(秋田県)，広島大学(広島県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 08 | 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 | 08 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 08 | Month | 20 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Prospective study
Multicenter research
Management information
Registered date
| 2015 | Year | 01 | Month | 08 | Day |
Last modified on
| 2017 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018568
