UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Survey on the impact of hypnotic usage in patients with chronic insomnia
Title of the study (Brief title)	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	Yuichi INOUE
Organization	Tokyo Medical University
Division name	Department of Somnology
Address	6-1-1 Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL	03-3351-6141
Email	inoue@somnology.com

Public contact
Name of contact person	Mina KOBAYASHI
Organization	Neuropsychiatric Research Institute
Division name	Japan Somnology Center
Address	1-24-10 Yoyogi, Shibuya-ku, Tokyo, Japan
TEL	03-3374-2016
Homepage URL
Email	kobayashi@somnology.com

Sponsor
Institute	Neuropsychiatric Research Institute
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018568