UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020178 |
|---|---|
| Receipt number | 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 21:08:54 |
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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)
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
saekik@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University School of Medicine.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023215
