UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058420 |
|---|---|
| Receipt number | R000066775 |
| Scientific Title | Sex difference in sensory gating with consideration of the menstrual cycle |
| Date of disclosure of the study information | 2025/07/31 |
| Last modified on | 2025/07/10 14:31:58 |
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Basic information
Public title
Sex difference in sensory gating with consideration of the menstrual cycle
Acronym
Sex difference in sensory gating with consideration of the menstrual cycle
Scientific Title
Sex difference in sensory gating with consideration of the menstrual cycle
Scientific Title:Acronym
Sex difference in sensory gating with consideration of the menstrual cycle
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sensory gating is a mechanism by which the brain selected sensory information processes and is an essential function for human survival. This function has been primary investigated using the P50 component of auditory evoked potentials (AEPs), and a reduction in the amplitude of the P50 has been reported in patients with schizophrenia. In other ward, patients with schizophrenia indicating impaired sensory gating compared to health groups. On the other hand, a study examining the relationship between gating in middle latency evoke potentials across somatosensory and auditory modalities in 20 healthy males suggested that early sensory gating level may be specific modality. However, influences by the menstrual cycle has not been clearly in previous studies. In our previous studies, we measured late activities of somatosensory and auditory evoked potentials following the P50 amplitude, examined their relationship with the menstrual cycle and sex differences. The results suggested that influence by the menstrual cycle on the sensory information processing may be differ depending on the modalities. Therefore, the present study aimed to investigate whether sex differences taking the menstrual cycle into account affect early sensory processing (i.e., sensory gating), which occurs prior to the late-phase activities.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the effects of sex differences taking the menstrual cycle into account on sensory gating in the human brain, we recorded somatosensory evoked potentials (SEPs) and auditory evoked potentials (AEPs) using electroencephalography (EEG) and evaluated the influence of both the menstrual cycle and sex differences. Female participants were assessed during two distinct phases; the menstrual phase (2-4 days after the onset of menstruation) and the ovulatory phase (2-3 days after a positive result using an ovulation prediction kit). Ovulation was evaluated via a urine based test. This approach allows us to examine differences in sensory gating attributable to the menstrual cycle and sex. As a result, we aim to clarify whether sensory information processing in the brain differs according to menstrual phase or biological sex.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Electrical Stimulation
Auditory Stimulation
EEG
Interventions/Control_2
Electrical Stimulation
Auditory Stimulation
EEG
Interventions/Control_3
Electrical Stimulation
Auditory Stimulation
EEG
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Right-handed normal adult men and women
Females are normal menstruating adults (menstrual cycle of 28 to 35 days)
Adults with no history of psychiatric or neurological disorders
Key exclusion criteria
Adults with no history of psychiatric or neurological disorders
Women with irregular menstruation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Anazawa |
Organization
Niigata University of Health and Welfare
Division name
Graduate School of Health and Welfare Studies
Zip code
950-3198
Address
1398 shimami-cho, kita-ku, Niigata city
TEL
070-2029-1720
hwd24012@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Anazawa |
Organization
Niigata University of Health and Welfare
Division name
Graduate School of Health and Welfare Studies
Zip code
950-3198
Address
1398 shimami-cho, kita-ku, Niigata city
TEL
070-2029-1720
Homepage URL
hwd24012@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
Niigata 950-3198, Japan
Tel
025-257-4500
hwd24012@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
| 2025 | Year | 07 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | 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
| 2025 | Year | 07 | Month | 10 | Day |
Last modified on
| 2025 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066775
