NIPH Clinical Trials Search

Sleep cycle research

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	normal pregnancy and delivary
Date of first enrollment	08/04/2026
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	Acquisition of fetal physiological signals using the Iris Monitor and neonatal electroencephalography using InSomnograf

Outcome(s)

Primary Outcome

The feasibility of acquiring and analyzing the following electroencephalographic parameters at within 7 days of birth, at postnatal day 14 days, and at postnatal day 28 days will be evaluated: Identification of sleep stages (REM, NREM, transitional sleep, and awake) Proportional distribution and cyclical changes of each sleep stage In addition, the study will evaluate whether sleep cycles can be clearly recorded and distinguished using EEG, including the success rate of visualization in terms of recording duration, noise level, and electrode attachment rate.

Secondary Outcome

Mode of delivery (vaginal delivery / elective cesarean section / emergency cesarean section): Included because birth-related stress and hormonal responses may influence neonatal sleep architecture. Perinatal medical interventions (respiratory support, medication administration, admission to an incubator, etc.): Included to evaluate changes in EEG patterns associated with the presence or absence of medical interventions. Neonatal background factors (birth weight, sex, gestational age): Included to explore associations between baseline characteristics and sleep architecture. Comparison with fetal electrocardiography obtained using the Iris Monitor (fetal ECG parameters measured at over 37 weeks of gestation): Included to examine the relationship between fetal autonomic nervous system activity and postnatal sleep cycles.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Female
Include criteria	Age over 18 years Normal pregnancy at over 28 weeks of gestation, with delivery at over 37 weeks Singleton pregnancy Written informed consent obtained from the participant Neonatal criteria 5) No abnormalities identified in the postnatal course (including previously undiagnosed congenital anomalies, hypoxia, metabolic disorders, etc.)
Exclude criteria	Cases in which fetal abnormalities or abnormal amniotic fluid volume are identified at the time of enrollment Cases deemed inappropriate for inclusion in this study by the principal investigator or sub-investigators Neonatal criteria Suspected neonatal asphyxia at birth (Apgar score at 5 minutes under 7, or umbilical cord blood pH under 7.1, or base excess under -12 mEq/L) Neonates in whom hypoxia has been identified after birth