UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020313
Receipt number 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 18:51:20

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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 or person

Institute

Tokyo Sleep Medical Center

Institute

Department

Personal name



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

Value
https://center6.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