UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015562 |
|---|---|
| Receipt number | R000017968 |
| Scientific Title | Measuring Plasma Orexin Concentrations in Narcolepsy and Idiopathic Hypersomnia |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2020/11/25 09:24:17 |
* 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
Measuring Plasma Orexin Concentrations in Narcolepsy and Idiopathic Hypersomnia
Acronym
Measuring Plasma Orexin Concentrations
Scientific Title
Measuring Plasma Orexin Concentrations in Narcolepsy and Idiopathic Hypersomnia
Scientific Title:Acronym
Measuring Plasma Orexin Concentrations
Region
| Japan |
Condition
Condition
Narcolepsy & idiopathic hypersomnia
Classification by specialty
| Neurology | Psychiatry | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1). The first purpose of this study is to measure the plasma concentrations of orexin A and B accurately.
Basic objectives2
Others
Basic objectives -Others
2). The second purpose is to investigate whether there are significant differences in the plasma orexin concentrations between the narcolepsy group, the idiopathic hypersomnia group, and the normal control group.
3). The third purpose is to show the fluctuation of the plasma orexin concentrations related to the wake-sleep cycle or eating behaviors in normal controls.
4). The fourth purpose is to present the normative range of the plasma orexin concentrations in normal subjects.
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
plasma orexin concentrations
Key secondary outcomes
sleepiness measured with the Multiple Sleep Latency Test (MSLT)
Epworth Sleepiness Scale (ESS)
Visual Analog Scale (VAS)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Blood samples are taken at 9:00, 11:00, 13:00, 15:00, and 17:00 in order to measure the plasma concentrations of orexin, glucose, insulin, leptin, adiponectin, cortisol, ACTH, progesterone, etc., and sleepiness is assessed with the Multiple Sleep Latency Test (MSLT) and Visual Analog Scale (VAS).
Patients with narcolepsy and idiopathic hypersomnia should stop taking stimulants, REM suppressing medications, hypnotics, and/or tranquilizers for 2 weeks before the MSLT, if possible.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The narcolepsy group and idiopathic hypersomnia group consist of patients whose symptoms and laboratory findings meet ICSD-2 (the International Classification of Sleep Disorders,2005) diagnostic criteria for narcolepsy and idiopathic hypersomnia respectively.
Key exclusion criteria
The control group consists of normal subjects without sleep disorders, mental disorders, the direct physiological effects of a substance (e.g., a sedative, hypnotic, or stimulant, etc.), and severe physical diseases.
Patients with anemia or renal failure are excluded from the narcolepsy group, the idiopathic hypersomnia group, and the control group.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeki Takei |
Organization
School of Medicine, Keio University
Division name
Department of Laboratory Medicine
Zip code
Address
35 Shinano-machi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-3353-1211(ext.62522)
takei.shigeki@jcom.zaq.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeki Takei |
Organization
School of Medicine, Keio University
Division name
Department of Laboratory Medicine
Zip code
Address
35 Shinano-machi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-3353-1211(ext.62522)
Homepage URL
takei.shigeki@jcom.zaq.ne.jp
Sponsor or person
Institute
Department of Laboratory Medicine, School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
Department of Laboratory Medicine, School of Medicine, Keio University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
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
慶應義塾大学病院中央臨床検査部(東京都)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | 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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2010 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 10 | 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
| 2014 | Year | 10 | Month | 30 | Day |
Last modified on
| 2020 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017968
