UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054999 |
|---|---|
| Receipt number | R000062813 |
| Scientific Title | The Relationship Between Premenstrual Syndrome Symptoms and Sleep During the Luteal Phase and Menstrual Phase in Sexually Mature Women |
| Date of disclosure of the study information | 2024/07/17 |
| Last modified on | 2024/07/17 17:49:10 |
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Basic information
Public title
The Relationship Between Premenstrual Syndrome Symptoms and Sleep During the Luteal Phase and Menstrual Phase in Sexually Mature Women
Acronym
The Relationship Between Premenstrual Syndrome Symptoms and Sleep During the Luteal Phase and Menstrual Phase in Sexually Mature Women
Scientific Title
The Relationship Between Premenstrual Syndrome Symptoms and Sleep During the Luteal Phase and Menstrual Phase in Sexually Mature Women
Scientific Title:Acronym
The Relationship Between Premenstrual Syndrome Symptoms and Sleep During the Luteal Phase and Menstrual Phase in Sexually Mature Women
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the relationship between premenstrual syndrome symptoms and sleep, including autonomic nervous system activity, during the luteal phase and menstrual phase in sexually mature women.
Basic objectives2
Others
Basic objectives -Others
Specifically, the study will identify the relationship between subjective premenstrual syndrome symptoms, subjective sleep quality as measured by a questionnaire, and sleep status as measured by a wearable device before and during menstruation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Premenstrual syndrome symptoms
Key secondary outcomes
Basal body temperature, OSA sleep inventory MA version, Heart rate, Stress level, sleep time, Light sleep, Deep sleep, REM sleep
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
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
Menstrual cycle is stable at 25-38 days, No major life cycle changes such as moving are expected during the experimental period, No low-capacity contraceptive pills have been taken for more than 3 months, No current diagnosis of gynecological disease, BMI between 18 and 25
Key exclusion criteria
Smoking habit, Taking sleeping pills, Pregnant or have a history of pregnancy or childbirth, Working in shifts
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Hisayo |
| Middle name | |
| Last name | Okayama |
Organization
Universtity of Tsukuba
Division name
Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
070-2645-5576
okayama@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Manami |
| Middle name | |
| Last name | Yaguchi |
Organization
Graduate School of Conperhensive Human Science, University of Tsukuba
Division name
Graduate Programs in Nursing Science, Degree Programs in Conprehensive Human Sciences
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
070-2645-5576
Homepage URL
s2321385@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee, Institute of Medicine, University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
Tel
029-853-3022
sien.ningenss@un.tsukuba.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 | 07 | Month | 17 | 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 | 06 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After recruitment and selection of the participants, explanation and consent are obtained, and measurement of basal body temperature is initiated. From about 6 days before the expected start of menstruation until 3 days after the start of menstruation, the participants will be asked to wear the smartwatch during sleep and answer a questionnaire.
Management information
Registered date
| 2024 | Year | 07 | Month | 17 | Day |
Last modified on
| 2024 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062813
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
