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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040427
Receipt No. R000045310
Scientific Title Relationship between biological data acquired by wearable device and brain function on neurological patients
Date of disclosure of the study information 2020/05/19
Last modified on 2020/05/18

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Basic information
Public title Relationship between biological data acquired by wearable device and brain function on neurological patients
Acronym Relationship between biological data acquired by wearable device and brain function
Scientific Title Relationship between biological data acquired by wearable device and brain function on neurological patients
Scientific Title:Acronym Relationship between biological data acquired by wearable device and brain function
Region
Japan

Condition
Condition neurological diseases
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study,e monitor the biological information of neurological patients continuously using a wearable device, and evaluate the relationships between changes of the biological data and cognitive functions and brain structures after treatments or invasive examinations. Furthermore, we try to establish new evaluation system on patient's ADL/QOL by assessing the chronological changes of biological data detected by the wearable device through admission, treatment and rehabilitation.
Basic objectives2 Others
Basic objectives -Others Evaluation of physical activity, sleep pattern, amount of conversation, skin temperature, MMSE, change of the brain structures, etc.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes amount of change of data acquired by wearable device during 2 weeks
Key secondary outcomes physical activity, sleep pattern, amount of conversation, skin temperature, MMSE, change of the brain structures

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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients who will be hospitalized in departments of neurosurgery or neurology and can wear a wearable sensor.
Key exclusion criteria Patients who can't wear the device because of problems of the hand joint or skin.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yasunori
Middle name
Last name Fujimoto
Organization Japan Organization of Occupational Health and Safety Osaka Rosai Hospital
Division name Department of Neurosurgery
Zip code 591-8025
Address 1179-3, Nagasone-cho, Kita-ku, Sakai, Osaka
TEL 072-252-3651
Email yfujimoto@osakah.johas.go.jp

Public contact
Name of contact person
1st name Yasunori
Middle name
Last name Fujimoto
Organization Japan Organization of Occupational Health and Safety Osaka Rosai Hospital
Division name Department of Neurosurgery
Zip code 591-8025
Address 1179-3, Nagasone-cho, Kita-ku, Sakai, Osaka
TEL 072-252-3651
Homepage URL
Email yfujimoto@osakah.johas.go.jp

Sponsor
Institute Japan Organization of Occupational Health and Safety Osaka Rosai Hospital
Institute
Department

Funding Source
Organization Japan Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japan Organization of Occupational Health and Safety Osaka Rosai Hospital
Address 1179-3, Nagasone-cho, Kita-ku, Sakai, Osaka
Tel 072-252-3651
Email 072-252-3651

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 独立行政法人 労働者健康安全機構 大阪労災病院(大阪府)

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 19 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 Enrolling by invitation
Date of protocol fixation
2020 Year 04 Month 01 Day
Date of IRB
2020 Year 04 Month 01 Day
Anticipated trial start date
2020 Year 05 Month 11 Day
Last follow-up date
2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2020 Year 05 Month 18 Day
Last modified on
2020 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045310

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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