UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053398 |
|---|---|
| Receipt number | R000060942 |
| Scientific Title | Prediction of Menstrual Associated Symptoms by Biometric Information during Sleep |
| Date of disclosure of the study information | 2024/01/21 |
| Last modified on | 2024/05/31 08:04:21 |
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Basic information
Public title
Prediction of Menstrual Associated Symptoms by Biometric Information during Sleep
Acronym
Prediction of Menstrual Associated Symptoms by Biometric Information during Sleep
Scientific Title
Prediction of Menstrual Associated Symptoms by Biometric Information during Sleep
Scientific Title:Acronym
Prediction of Menstrual Associated Symptoms by Biometric Information during Sleep
Region
| Japan |
Condition
Condition
Healthy women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To clarify the variation in the response suppression function associated with premenstrual symptoms during the menstrual cycle.
2) To identify predictive indices of premenstrual symptoms and cognitive function fluctuations based on biological information obtained during sleep.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
estimated core body temperature and chest skin temperature, sublingual temperature upon awakening, electrocardiogram, inhibitory function, premenstrual symptoms, luteinizing hormone (LH) surge
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Biometric measurements during sleep, evaluation of premenstrual symptoms and cognitive function
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
healthy woman
Key exclusion criteria
Those taking low-dose pills or LEP, those with amenorrhea, those with neurological, psychiatric, respiratory, circulatory, or gastrointestinal disorders, or those with a history of such disorders.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Sato |
Organization
Niigata University of Health and Welfare
Division name
Dep. Health and Sports
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata city
TEL
025-257-4624
daisuke@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Sato |
Organization
Niigata University of Health and Welfare
Division name
Dep. Health and Sports
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata city
TEL
025-257-4624
Homepage URL
daisuke@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
TOPPAN Edge Inc.
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
Niigata University of Health and Welfare
Address
Shimami-cho 1398, Kita-ku, Niigata city
Tel
025-257-4624
daisuke@nuhw.ac.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
| 2024 | Year | 01 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 20 | Day |
Last modified on
| 2024 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060942
