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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020178
Receipt No. R000023215
Scientific Title A validation study of ambulatory measurement of biological rhythms.
Date of disclosure of the study information 2015/12/13
Last modified on 2018/06/17

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Basic information
Public title A validation study of ambulatory measurement of biological rhythms.
Acronym A validation study of ambulatory measurement of biological rhythms.
Scientific Title A validation study of ambulatory measurement of biological rhythms.
Scientific Title:Acronym A validation study of ambulatory measurement of biological rhythms.
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the results between newly-developed measurements and standard measurements about bed time/rising time (posture sensor vs. self-reported sleep diary), sleep quality (actigraph vs. Electroencephalogram: EEG), body temperature (skin temperature and rectal temperature) and blood pressure (tonometric ambulatory BP vs. conventional ambulatory BP).
Basic objectives2 Others
Basic objectives -Others To assess the validity of measuremnt methods.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Based on the measurement data of bed time/rising time for 7 days using two methods such as ambulatory posture sensor and self-reported sleep diary, we will assess the agreement between the two methods in terms of mean difference and correlation.

Of whole session for 7 days, the measurement at the first night from 8 PM to 7 AM was conducted at climate
chamber with standardized environment (22 degree C, <30lux). For the rest of session, the measurement was continued at real life situation at natural home settings.
Key secondary outcomes Based on the measurement data of sleep parameters for 7 nights using two methods such as actigraph and EEG, we will assess the agreement between the two methods in terms of mean difference and correlation.

Based on the measurement data of daytime BP, nighttime BP, dipping, and morning BP surge for 3 days using two methods such as tonometric ABPM and conventional ABPM, we will assess the agreement between the two methods in terms of mean difference and correlation.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 We will conduct measurement at a climate chamber with standardized environment (22 degree C, 30lux) at the initial night from 8PM to 7AM. In addition, we will measure bed time and rising time at home for 6 nights.
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
60 years-old >
Gender Male and Female
Key inclusion criteria Male and female with eligible age (>=20, <60 years old).
Key exclusion criteria Sever insomnia and depression.
Target sample size 20

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 0744-22-3051(2244)
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 0744-22-3051(2244)
Homepage URL
Email saekik@naramed-u.ac.jp

Sponsor
Institute Nara Medical University School of Medicine.
Institute
Department

Funding Source
Organization Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Nara Women's University
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 奈良県立医科大学(奈良県)
Nara Medical University School of Meidicine (Nara, Japan)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 13 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 Completed
Date of protocol fixation
2015 Year 11 Month 05 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 10 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 13 Day
Last modified on
2018 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023215

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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