jRCT ロゴ

臨床研究等提出・公開システム

Top

Japanese

April. 14, 2026

April. 14, 2026

jRCT1030260046

Sex-Dependent Effects of Acute Normobaric Hypoxia on Dynamic Cerebral Autoregulation

A Study to Examine Sex Differences in the Effects of Acute Hypoxic Exposure on Cerebral Autoregulation

Kato Tomokazu

Nihon University School of Medicine

1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan

+81-3-5801-6041

kato.tomokazu@nihon-u.ac.jp

Kato Tomokazu

Nihon University School of Medicine

1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan

+81-358016041

kato.tomokazu@nihon-u.ac.jp

Recruiting

April. 14, 2026

40

Interventional

randomized controlled trial

single blind

placebo control

crossover assignment

basic science

1) Individuals aged 18 to 35 years at the time of obtaining informed consent
2) Individuals who have received a thorough explanation regarding participation in this study and have provided voluntary consent based on full understanding
3) Individuals confirmed to be in good health based on medical interview and health examination results
4) Females with a normal menstrual cycle length (25-38 days)
5) Individuals in whom stable cerebral blood flow velocity waveforms can be obtained by transcranial Doppler ultrasonography in the supine resting position

1) Individuals from whom consent to participate in the study could not be obtained
2) Individuals with, or with a history of, cardiovascular disease (including hypertension and arrhythmia), neurological disease (including cerebrovascular disease and epilepsy), respiratory disease (including bronchial asthma and COPD), autonomic nervous system dysfunction, or severe systemic disease; and individuals with anemia that has not improved with treatment
3) Individuals who show any of the following findings on screening examination (blood pressure measurement and electrocardiography): systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg, or electrocardiographic abnormalities such as atrial fibrillation, atrial flutter, or frequent premature contractions
4) Individuals with a history of allergy or skin reactions to ultrasound gel
5) Females who regularly use hormonal agents such as oral contraceptives, those with irregular menstrual cycles, or those who are pregnant
6) Females for whom it is determined that scheduling the experiment during the follicular phase of the menstrual cycle is not feasible
7) Smokers
8) Individuals deemed inappropriate as study participants by the principal investigator

18age old over
35age old under

Both

Healthy adults

Hypoxic condition: Inhalation of 21% oxygen for 10 minutes,
followed by inhalation of 15% oxygen (hypoxia) for 10 minutes.

Control condition: Inhalation of 21% oxygen for 10 minutes,
followed by inhalation of 21% oxygen for 10 minutes.
Each condition is conducted on separate days.
The order of conditions is assigned by single-blind randomized crossover allocation.

dynamic cerebral autoregulation indices (Gain, Phase, Coherence)

Steady-state mean blood velocity in the middle cerebral artery, Non invasive intracranial pressure index

Japan Society for the Promotion of Science (JSPS)
Nihon University School of Medicine, Ethics Committee
30-1, Oyagichi-Kamicho, Itabashi, Tokyo, Tokyo

+81-3-3972-8111

med.kenjim@nihon-u.ac.jp
Approval

Nov. 18, 2025

No

none