UMIN-CTR Clinical Trial

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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