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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000015562
Receipt No. 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 2017/06/13

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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
Last 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)
Email takei.shigeki@jcom.zaq.ne.jp

Public contact
1st 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
Email takei.shigeki@jcom.zaq.ne.jp

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

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
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 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 Enrolling by invitation
Date of protocol fixation
2010 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 25 Day
Last follow-up date
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
2017 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017968

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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