UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054382 |
|---|---|
| Receipt number | R000062112 |
| Scientific Title | Empirical study on confirmation and evaluation of temperature changes in the menstrual cycle (biphasic) using wearable devices capable of continuous temperature measurement (developed products) -Verification of reliability, validity, and clinical usefulness of confirmation and evaluation of temperature changes (biphasic) in the menstrual cycle- |
| Date of disclosure of the study information | 2024/06/07 |
| Last modified on | 2024/11/13 12:01:40 |
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Basic information
Public title
Empirical study on confirmation and evaluation of temperature changes in the menstrual cycle (biphasic) using wearable devices capable of continuous temperature measurement (developed products)
-Verification of reliability, validity, and clinical usefulness of confirmation and evaluation of temperature changes (biphasic) in the menstrual cycle-
Acronym
Empirical study on confirmation of temperature changes in the menstrual cycle (biphasic) using wearable devices (developed products)
Scientific Title
Empirical study on confirmation and evaluation of temperature changes in the menstrual cycle (biphasic) using wearable devices capable of continuous temperature measurement (developed products)
-Verification of reliability, validity, and clinical usefulness of confirmation and evaluation of temperature changes (biphasic) in the menstrual cycle-
Scientific Title:Acronym
Empirical study on confirmation of temperature changes in the menstrual cycle (biphasic) using wearable devices (developed products)
Region
| Japan |
Condition
Condition
Female with menstrual cycle
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to demonstrate that the data continuously measured during sleep using the developed wearable device (hereinafter referred to as abdominal temperature) can capture biphasic temperature changes associated with the menstrual cycle, similar to the data measured in the mouth with a conventional women's thermometer at the time of waking up (hereinafter referred to as "mouth temperature"). The purpose of this service is to predict the ovulation period and the next menstrual cycle from the analysis results of measurement data, and to provide users with prediction of premenstrual syndrome based on understanding the correct menstrual cycle.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Confirmation of the feasibility of using abdominal temperature as a method of biphasic confirmation of the menstrual cycle
Key secondary outcomes
(1) Number of days in the high-temperature phase determined from the point of change in abdominal temperature and mouth temperature
(2) Correlation coefficient between the typical temperature of the day and the temperature of the mouth
(3) Validity as a continuous measurement method
(4) Verification of the accuracy of the menstrual cycle prediction model
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
| 25 | years-old | <= |
Age-upper limit
| 54 | years-old | >= |
Gender
Female
Key inclusion criteria
Women with a stable menstrual cycle in the last 3 cycles (28-35 day cycles)
Key exclusion criteria
1. Those who are currently attending a gynecological clinic and are undergoing treatment, those who have a history of uterine or ovarian surgery, and those who have a history or current infection of gynecological malignancies such as uterine cancer, ovarian cancer, and breast cancer
2. Those who take oral contraceptives such as pills or other female hormones
3. Those who are unable to participate due to physical or mental health reasons at the discretion of a physician
4. Persons who are unable to obtain consent due to personal circumstances, etc.
5. Those who are judged by the principal investigator to be inappropriate as the subject of this study
6. Those who are unable to communicate in Japanese
7. Those who are unable to connect to their own WIFI when sleeping, in an environment where 4G or 5G communication is not possible
8. Those who are pregnant
9. Those who are likely to become pregnant during the course (excluding sudden ones) * However, if it is found that you are pregnant during participation, you can continue
10. Those who are planning to travel or on a business trip and have to change their sleeping place (excluding sudden ones)
11. Those who work the night shift
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Asako |
| Middle name | |
| Last name | Taniuchi |
Organization
EMICLE CLINIC
Division name
EMICLE CLINIC
Zip code
420-0033
Address
2F Sanko Bldg. 3-6 Showa-cho, Aoi-ku, Shizuoka city, Shizuoka, 420-0033, Japan
TEL
054-204-1186
a_taniuchi@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuma |
| Middle name | |
| Last name | Toda |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place 5F, 5-27-1 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
toda.kazuma@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Murata Manufacturing Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2024 | Year | 06 | Month | 07 | 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
35
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
| 2024 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, with the cooperation of healthy women with menstrual cycles, abdominal temperature (temperature calculated using an existing algorithm built at Murata Manufacturing Co., Ltd. based on the temperature inside the clothes and the temperature inside the clothing: hereinafter referred to as the abdominal temperature) and the temperature in the mouth were collected in parallel for three cycles, and the correlation between each variable and the point of change between the two phases were evaluated by statistical analysis. In addition, the physical and mental situation is collected in the form of a daily questionnaire. Using these data, we will construct a menstrual cycle prediction model.
Management information
Registered date
| 2024 | Year | 05 | Month | 13 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062112
