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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025441
Receipt No. R000029281
Scientific Title Estimation of sleep improvement after the administration of OAB drugs and ramelteon using a contactless biomotion sensor
Date of disclosure of the study information 2016/12/27
Last modified on 2016/12/27

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Basic information
Public title Estimation of sleep improvement after the administration of OAB drugs and ramelteon using a contactless biomotion sensor
Acronym Estimation of sleep improvement after the administration of OAB drugs and ramelteon using a contactless biomotion sensor
Scientific Title Estimation of sleep improvement after the administration of OAB drugs and ramelteon using a contactless biomotion sensor
Scientific Title:Acronym Estimation of sleep improvement after the administration of OAB drugs and ramelteon using a contactless biomotion sensor
Region
Japan

Condition
Condition OAB with insomnia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Subjective and objective estimation of sleep improvement after the administration of OAB drugs and ramelteon using a contactless biomotion sensor
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes hours of undisturbed sleep
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The contactless biomotion sensor, N-QOL, IPSS, OABSS before and after drug treatment
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria OAB
nocturia 2 and more a night
insomnia
Key exclusion criteria 1. PVR >50mL
2. active urinary tract infection
3. malignant tumor of lower urinary tract
4. surgery for lower urinary tract in the past 3 months
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazumasa Torimoto
Organization Nara Medical University
Division name Urology
Zip code
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Email torimoto@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazumasa Torimoto
Organization Nara Medical University
Division name Urology
Zip code
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Homepage URL
Email torimoto@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Nara Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 27 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 Terminated
Date of protocol fixation
2014 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 01 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
2016 Year 12 Month 27 Day
Last modified on
2016 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029281

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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