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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000019223
Receipt No. R000022116
Scientific Title Sleep,hemodynamics and autonomic activations in patients in the cardiovascular care unit
Date of disclosure of the study information 2015/10/10
Last modified on 2015/10/03

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Basic information
Public title Sleep,hemodynamics and autonomic activations in patients in the cardiovascular care unit
Acronym Sleep,hemodynamics and autonomic activations in patients in the cardiovascular care unit
Scientific Title Sleep,hemodynamics and autonomic activations in patients in the cardiovascular care unit
Scientific Title:Acronym Sleep,hemodynamics and autonomic activations in patients in the cardiovascular care unit
Region
Japan

Condition
Condition cardiovascular diseases in acute management
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to reveal the influence of the rest by sleeping on sympathetic activities and hemodynamic changes in patients in cardiovascular care unit.
Basic objectives2 Others
Basic objectives -Others The relationship between the rest by sleeping, sympathetic activity and hemodynamic changes.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sympathetic activity and hemodynamic changes during sleep in patients in cardiovascular care unit.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ・admission to cardiovascular care unit
・necessity for intra-arterial line for therapeutic purposes
・consent to participate in this study
Key exclusion criteria ・inability to give consent(e.g. endotracheal intubation,remarkable dementia)
・requirement of intravenous beta-blocking agents
・taking alpha-blockers
・requirement of intravenous inotropes
・being artificially paced
・frequent arrhythmias(e.g. atrial fibrillation)
・requirement of intra-aortic balloon pumping
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Saki Hasegawa
Organization Saitama Medical University, International Medical Center
Division name Cardiology
Zip code
Address 1397-1, Yamane, Hidaka, Saitama
TEL 042-984-4111
Email h_hase@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Saki Hasegawa
Organization Saitama Medical University, International Medical Center
Division name Cardiology
Zip code
Address 1397-1, Yamane, Hidaka, Saitama
TEL 042-984-4111
Homepage URL
Email h_hase@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University, International Medical Center
Institute
Department

Funding Source
Organization Saitama Medical University, International Medical Center
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
2015 Year 10 Month 10 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 Preinitiation
Date of protocol fixation
2015 Year 10 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is prospective observational study about patients admitted to CCU from October 2015.

Management information
Registered date
2015 Year 10 Month 03 Day
Last modified on
2015 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022116

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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