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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036720
Receipt No. R000041839
Scientific Title Examination to wear blue-blocking glasses for migraine patients
Date of disclosure of the study information 2019/06/01
Last modified on 2019/07/26

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Basic information
Public title Examination to wear blue-blocking glasses for migraine patients
Acronym Examination to wear blue-blocking glasses for migraine patients
Scientific Title Examination to wear blue-blocking glasses for migraine patients
Scientific Title:Acronym Examination to wear blue-blocking glasses for migraine patients
Region
Japan

Condition
Condition migraine
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study uses blue-blocking glasses for migraine patients and investigates whether it is effective in migraine relief.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We investigate the number of days and medication days due to migraine for 3 months.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Wearing blue-blocking glasses for 1 month
Interventions/Control_2 Wearing placebo glasses for 1 month
Interventions/Control_3 No glasses attached
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 Migraine with photosensitivity
Key exclusion criteria Migraine without photosensitivity
Target sample size 26

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Hirata
Organization Dokkyo Medical University
Division name Neurology
Zip code 3210293
Address 880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi
TEL 0282861111
Email hirata@dokkyomed.ac.jp

Public contact
Name of contact person
1st name Eisei
Middle name
Last name Hoshiyama
Organization Dokkyo Medical University
Division name Neurology
Zip code 3210293
Address 880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi
TEL 0282861111
Homepage URL
Email eisei@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization Mitsui Chemicals, Inc.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JPN

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

IRB Contact (For public release)
Organization Dokkyo Medical University
Address 880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi
Tel 0282861111
Email eisei@dokkyomed.ac.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
2019 Year 06 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 05 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 12 Day
Last modified on
2019 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041839

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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