UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051467 |
|---|---|
| Receipt number | R000058194 |
| Scientific Title | A study for a Predictive Data Model for Symptoms of PremenstrualSyndrome using a Wearable Device |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2024/01/09 09:50:17 |
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Basic information
Public title
A study for a Predictive Data Model for Symptoms of Premenstrual Syndrome using a Wearable Device
Acronym
A study for a Predictive Data Model for Symptoms of PremenstrualSyndrome using a Wearable Device
Scientific Title
A study for a Predictive Data Model for Symptoms of PremenstrualSyndrome using a Wearable Device
Scientific Title:Acronym
A study for a Predictive Data Model for Symptoms of PremenstrualSyndrome using a Wearable Device
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Quantification of PMS symptoms and blood sugar fluctuations in healthy adult women by comparing self-administered questionnaire response scores, exercise/sleep-related information obtained from sensing devices, and data such as heart rate and blood oxygen concentration try.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Since this study is a hypothesis-exploratory study, the correlations between objective evaluation indices that can be obtained from the sensing devices and subjective evaluation indices obtained from the questionnaire scores will be comprehensively compared.
Objective metrics that can be obtained from sensing devices
*Stress related values
*Sleep efficiency related value
*Momentum-related value
*Blood oxygen concentration
*Amount of activity
*Information that can be obtained from other sensing devices
Subjective evaluation
*MDQ
*Score of research subject questionnaire
When there is a request from the person to wear
*Blood glucose related values obtained from continuous blood glucose meter data
Key secondary outcomes
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1.Females aged between 18 and 60 at the time of informed consent
2.Those who own a smartphone terminal on which applications can be installed, have no plans to change models during the research period, and agree to the terms of use regarding the sensing devices and applications used in this research.
3.Those who can obtain written consent to participate in this research and to provide information to this research before participating in this research
Key exclusion criteria
1.Those who have difficulty in health management due to perioperative period, infection, or disease under treatment
2.Patients who were taking hormonal drugs such as pills, antipsychotic drugs within 2 months from the start of the study, those who were diagnosed with other mental disorders, and those who were diagnosed with gynecological disorders
3.Those who have not had menstruation for 3 months or more (secondary amenorrhea), those who are menopausal,those who are pregnant,or those who are breastfeeding
4.Those who are judged by the research director to be difficult to use the sensing device
5.Implanting a device that can affect heart rate, such as a pacemaker
depressed person
6.Persons using drugs that can affect heart rate
7.Subjects who may develop skin rashes due to continuous use of the sensing device
8.Others who are judged by the principal investigator to be inappropriate to participate in this research
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazumichi |
| Middle name | |
| Last name | Minato |
Organization
TechDoctor,Inc.
Division name
CEO
Zip code
141-0021
Address
Meguro Center building 8F,Kamiosaki3-2-1,Shinagawa-ku,Tokyo,Japan
TEL
03-5476-8889
minato@technology-doctor.com
Public contact
Name of contact person
| 1st name | Kazumichi |
| Middle name | |
| Last name | Minato |
Organization
TechDoctor,Inc.
Division name
CEO
Zip code
141-0021
Address
Meguro Center building 8F,Kamiosaki3-2-1,Shinagawa-ku,Tokyo,Japan
TEL
03-5476-8889
Homepage URL
minato@technology-doctor.com
Sponsor or person
Institute
TechDoctor,Inc.
Institute
Department
Personal name
Funding Source
Organization
LOTTE CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
LOTTE CO., LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JCCR
Address
Minamiikebukuro1-13-23,Toshima-ku,Tokyo,Japan
Tel
03-6869-7022
jccr-info@jccr.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
| 2023 | Year | 07 | 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
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
4.1. Research period
Ethics review committee approval date-March 2024 (planned)
4.2. Registration Period
Research subject registration start date: Ethics review committee approval date to September 2023 (planned)
4.3. Observation period
Last observation date of the last research subject: January 2024 observation period (planned)
Management information
Registered date
| 2023 | Year | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058194
| Research Plan | |
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| Research case data specifications | |
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| Research case data | |
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