UMIN-CTR Clinical Trial

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)
Email	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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017968