UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028125
Receipt No. R000032193
Scientific Title Effect of blue-blocking glasses in bipolar disorder with sleep onset insomnia: a randomized, double-blind, placebo-controlled study
Date of disclosure of the study information 2017/07/07
Last modified on 2019/07/09

* 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 Effect of blue-blocking glasses in bipolar disorder with sleep onset insomnia: a randomized, double-blind, placebo-controlled study
Acronym Effect of blue-blocking glasses in bipolar disorder with sleep onset insomnia
Scientific Title Effect of blue-blocking glasses in bipolar disorder with sleep onset insomnia: a randomized, double-blind, placebo-controlled study
Scientific Title:Acronym Effect of blue-blocking glasses in bipolar disorder with sleep onset insomnia
Region
Japan

Condition
Condition Bipolar disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate of efficacy and safety for blue light blocking glasses in bipolar disorder.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes VAS (visual analogue mood scales)for assessment of sleep quality
Key secondary outcomes Montgomery Asberg Depression Rating Scale
Young Mania Rating Scale
Clinical global impression
sleep diary
Insomnia Severity Index
morning and evening question
Actiwatch

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Wear blue light blocking glasses from 20:00 until bedtime every evening for two weeks.
Interventions/Control_2 Wear placebo glasses (blocking only ultraviolet light) from 20:00 until bedtime every evening for two 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
18 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-V) diagnosis of bipolar disorders outpatient.
Score of the Insomnia Severity Index is 8 points or more
Key exclusion criteria Marked suicidal ideation.
psychotic disorders, substance abuse, shift work
Target sample size 52

Research contact person
Name of lead principal investigator
1st name Esaki
Middle name
Last name Yuichi
Organization Okehazama Hospital
Division name Medical office
Zip code 470-1168
Address 3-879 sakae minamikan, toyoake, aichi
TEL 0562-97-1361
Email esakiz@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Esaki
Middle name
Last name Yuichi
Organization Okehazama Hospital
Division name Medical office
Zip code 470-1168
Address 3-879 sakae minamikan, toyoake, aichi
TEL 0562-97-1361
Homepage URL
Email esakiz@fujita-hu.ac.jp

Sponsor
Institute Okehazama Hospital
Institute
Department

Funding Source
Organization Non profit organization
The Neuroscience Research Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Okehazama Hospital
Address 3-879 sakae minamikan, toyoake, aichi
Tel 0562-97-1361
Email crc-tsuboi.so@seishinkai-kokoro.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
2017 Year 07 Month 07 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 43
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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 07 Day
Date of IRB
2019 Year 08 Month 02 Day
Anticipated trial start date
2017 Year 08 Month 02 Day
Last follow-up date
2019 Year 02 Month 13 Day
Date of closure to data entry
2019 Year 03 Month 01 Day
Date trial data considered complete
2019 Year 03 Month 01 Day
Date analysis concluded
2019 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 07 Day
Last modified on
2019 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032193

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.