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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039996
Receipt No. R000045605
Scientific Title Evaluation of sleep stage analysis using a simplified electroencephalograph and the relationship between sleep-related hormones and sleep stages in critically ill patients with sepsis
Date of disclosure of the study information 2020/04/01
Last modified on 2020/03/31

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Basic information
Public title Evaluation of sleep stage analysis using a simplified electroencephalograph and the relationship between sleep-related hormones and sleep stages in critically ill patients with sepsis
Acronym Evaluation of sleep stage analysis using a simplified electroencephalograph and the relationship between sleep-related hormones and sleep stages in critically ill patients with sepsis
Scientific Title Evaluation of sleep stage analysis using a simplified electroencephalograph and the relationship between sleep-related hormones and sleep stages in critically ill patients with sepsis
Scientific Title:Acronym Evaluation of sleep stage analysis using a simplified electroencephalograph and the relationship between sleep-related hormones and sleep stages in critically ill patients with sepsis
Region
Japan

Condition
Condition Patients who agreement with Sepsis-3 criteria
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the usefulness of a simplified electroencephalograph for monitoring sleep electroencephalogram in patients with sepsis.

The purpose of this study is to clarify the changes of humoral mechanism in patients with sepsis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Agreement rate between PSG and EEG sensor ZA-X score in patients with sepsis

Rhythmic changes in blood melatonin and orexin concentrations in patients with sepsis and their relationship with sleep EEG
Key secondary outcomes Relationship between blood melatonin concentration, blood orexin concentration and delirium

Relationship between sleep efficiency and mortality

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
20 years-old <=
Age-upper limit
200 years-old >=
Gender Male and Female
Key inclusion criteria Patients 18 years and older who agreement the Sepsis-3 criteria requiring invasive ventilation management in the ICU
Key exclusion criteria We excluded the following patients:
1)History of apparent central nervous system disease (stroke, head injury, central nervous system infection, brain tumor, after brain surgery, after cardiopulmonary arrest resuscitation, etc.)
2)History of psychiatric disorders / dementia
3)Alcohol and other poisoning patients
4)tracheotomy patient
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hiroomi
Middle name
Last name Tatsumi
Organization Sapporo Medical University
Division name Department of Intensive Care Medicine
Zip code 064-8543
Address South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan
TEL +81-11-611-2111
Email jp.haruna@hotmail.co.jp

Public contact
Name of contact person
1st name JUNPEI
Middle name
Last name HARUNA
Organization Sapporo Medical University, School of Medicine.
Division name Department of Intensive Care Medicine
Zip code 064-8543
Address South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan
TEL +81-11-611-2111
Homepage URL http://sapmedicu.com/
Email jp.haruna@hotmail.co.jp

Sponsor
Institute Sapporo Medical University
Institute
Department

Funding Source
Organization Self funding
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 Sapporo Medical University
Address South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan
Tel +81-11-611-2111
Email jp.haruna@hotmail.co.jp

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
2020 Year 04 Month 01 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 Open public recruiting
Date of protocol fixation
2020 Year 02 Month 01 Day
Date of IRB
2018 Year 10 Month 01 Day
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Non

Management information
Registered date
2020 Year 03 Month 31 Day
Last modified on
2020 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045605

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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