UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014154 |
|---|---|
| Receipt number | 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 09:32:51 |
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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
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
shimizu-toshi@umin.ac.jp
Sponsor or person
Institute
Department of Neurology, School of Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016479
