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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014154
Receipt No. R000016479
Scientific Title Clinical research on Sleep Disorders in Primary Headache Patients
Date of disclosure of the study information 2014/07/01
Last modified on 2016/03/25

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Basic information
Public title Clinical research on Sleep Disorders in Primary Headache Patients
Acronym SDPH
Scientific Title Clinical research on Sleep Disorders in Primary Headache Patients
Scientific Title:Acronym SDPH
Region
Japan

Condition
Condition Migraine
Chronic migraine
Tension-type headache
Cluster headache
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We compare sleep disorders among migraine, chronic migraine, tension-type headache and cluster headaache patients.
Basic objectives2 Others
Basic objectives -Others Sleep disorders and nightmares have been reported in migraine patients, which may suggest the involvement of rapid eye movement (REM) sleep regulation in migraine. However, the relationship between migraine and REM sleep behaviour disorder (RBD) remains unclear.Therefore, we explore RBD in primary headache patients.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Total score of below scales in primary headache patients.
#1. Pittsburgh Sleep Quality Index
#2. Epworth Sleepiness Scale
#3. RBD screening questionnaires
Key secondary outcomes Total score of below scales in primary headache patients.
#1. Headache Impact Test-6 (Japanese version)

Base
Study type

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Prevention
Type of intervention
Device,equipment Other
Interventions/Control_1 Headache Impact Test-6 (Japanese version)
Interventions/Control_2 RDB Screening Questionnaires
Interventions/Control_3 Pittsburgh Sleep Quality Index
Interventions/Control_4 Epworth Sleepiness Scale
Interventions/Control_5 Measurement the ratio of REM sleep using the sleep scan
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Headache patients, who are attending the neurology outpatient clinic in the Keio University hospital, obtained the informed consent and fulfilled the diagnositic criteria of the international headache society, are included in this study .
Key exclusion criteria Headache patients, who are attending the neurology outpatient clinic in the Keio University hospital and not obtained the informed consent, are excluded in this study .
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Suzuki
Organization School of Medicine, Keio University
Division name Department of Neurology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3787
Email nrsuzuki@a2.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiko Shimizu
Organization School of Medicine, Keio University
Division name Department of Neurology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3788
Homepage URL
Email shimizu-toshi@umin.ac.jp

Sponsor
Institute Department of Neurology, School of Medicine, Keio University
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 07 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 Terminated
Date of protocol fixation
2014 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
2016 Year 03 Month 01 Day
Date of closure to data entry
2016 Year 03 Month 01 Day
Date trial data considered complete
2016 Year 03 Month 01 Day
Date analysis concluded
2016 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2014 Year 06 Month 03 Day
Last modified on
2016 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016479

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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