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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020313
Receipt No. R000023440
Scientific Title The effects of Belsomra on sleep of REM sleep behavior disorder measured by portable polysomnography
Date of disclosure of the study information 2016/01/15
Last modified on 2016/04/18

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Basic information
Public title The effects of Belsomra on sleep of REM sleep behavior disorder measured by portable polysomnography
Acronym The effects of Belsomra on sleep of REM sleep behavior disorder measured by portable polysomnography
Scientific Title The effects of Belsomra on sleep of REM sleep behavior disorder measured by portable polysomnography
Scientific Title:Acronym The effects of Belsomra on sleep of REM sleep behavior disorder measured by portable polysomnography
Region
Japan

Condition
Condition REM sleep behavior disorder
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effects of Belsomra on sleep of REM sleep behavior disorder measured by portable polysomnography
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of sleep measured by portable polysomnography on the night of Belsomra and the first Belsomra free night
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The night of 4-20mg Belsomra use and the first night of Belsomra withdrawal
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
24 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria REM sleep behavior disorder diagnosed by The International Classification of Sleep Disorders Third Edition (ICSD-3)
Key exclusion criteria The other sleep disorders
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuro Endo
Organization Tokyo Sleep Medical Center
Division name Sleep Clinic Chofu
Zip code
Address 2-53-1 Kojima-cho Chofu-shi Tokyo 182-0026 Japan
TEL 0424900700
Email takuro@sleep-t.com

Public contact
Name of contact person
1st name
Middle name
Last name Takuro Endo
Organization Tokyo Sleep Medical Center
Division name Sleep Clinic Chofu
Zip code
Address 2-53-1 Kojima-cho Chofu-shi Tokyo 182-0026 Japan
TEL 0424900700
Homepage URL http://www.sleepmedicine-tokyo.com/
Email takuro@sleep-t.com

Sponsor
Institute Tokyo Sleep Medical Center
Institute
Department

Funding Source
Organization Tokyo Sleep Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 スリープクリニック調布(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 15 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
Suvorexant is effective for RBD patients.
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
2015 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2015 Year 08 Month 20 Day
Date of closure to data entry
2016 Year 03 Month 09 Day
Date trial data considered complete
2016 Year 03 Month 09 Day
Date analysis concluded
2016 Year 03 Month 09 Day

Other
Other related information The IRB defined this study as a retrospective observation study and allowed to obtain necessary data from the patients on February 12, 2016.

Management information
Registered date
2015 Year 12 Month 22 Day
Last modified on
2016 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023440

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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