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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002696
Receipt No. R000003220
Scientific Title Randomized control trial about the influence of room temperature on morning blood pressure surge.
Date of disclosure of the study information 2009/11/01
Last modified on 2014/01/07

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Basic information
Public title Randomized control trial about the influence of room temperature on morning blood pressure surge.
Acronym Randomized control trial about the influence of room temperature on morning blood pressure surge.
Scientific Title Randomized control trial about the influence of room temperature on morning blood pressure surge.
Scientific Title:Acronym Randomized control trial about the influence of room temperature on morning blood pressure surge.
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the suppressive effect of room-heating on morning blood pressure surge.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Sleep-trough Morning Blood Pressure Surge :defined as the morning Systolic Blood Pressure(SBP) minus the lowest SBP at night.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Dose comparison
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Subjects are required to stay in the room from 20:00 to 8:00 on the next day. Within the period, the room temperature will be kept at 12 degree C. Subjects can freely adjust the amount of clothes and blanket.
Interventions/Control_2 Subjects are required to stay in the room from 20:00 to 8:00 on the next day. Within the period, the room temperature will be kept at 22 degree C. Subjects can freely adjust the amount of clothes and blanket.
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
18 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria Male and female aged from 18 to 60.
Key exclusion criteria Patients receiving medications for hypertension, diabetes mellitus, heart failure, hemodialysis, and having past history of stroke.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keigo Saeki
Organization Nara Medical University School of medicine.
Division name Department of Community Health and Epidemiology
Zip code
Address 840 Shijo-cho Kashihara-shi Nara Japan
TEL 0744-29-8841
Email saekik@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keigo Saeki
Organization Nara Medical University School of medicine.
Division name Department of Community Health and Epidemiology
Zip code
Address 840 shijo-cho, kashihara-shi, Nara, Japan
TEL 0744-29-8841
Homepage URL
Email k-saeki@umin.ac.jp

Sponsor
Institute Department of Community Health and Epidemiology Nara Medical University School of medicine.
Institute
Department

Funding Source
Organization Daiwa House Industry Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Daiwa House Industry Co., Ltd
Central Research Laboratory
Name of secondary funder(s) Nara Women's University Faculty of Human Life and Environment Department of Environmental Health

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
2009 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2009 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2010 Year 04 Month 01 Day
Date of closure to data entry
2010 Year 05 Month 01 Day
Date trial data considered complete
2010 Year 06 Month 01 Day
Date analysis concluded
2010 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 11 Month 01 Day
Last modified on
2014 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003220

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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