Ireland
--:--IST
Latest
Clinical Trials in France / NCT04317677
Recruiting Not applicable

Effects of Bladder Voiding on Sleep Architecture in Infants

NCT04317677 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2020-12-09
Last updated
2025-01-30

Condition(s) studied

Sleep

Investigational drug(s) / intervention(s)

Study of the effect of bladder voiding on sleep fragmentation during day and night sleep

Study of the effect of bladder voiding on sleep fragmentation during day and night sleep: Vigilance state of babies will be continuously recorded during the first 24 hours of hospitalization by polysomnography and actigraphy. In parallel, bladder voiding episodes will be detected with an innovative device placed on babies diapers.

Study summary

Sleep changes rapidly during the first year of life. Brain maturation is accompanied by sleep consolidation in several episode during day and night (daytime naps and night sleep) and progressive organization during the 24h period (more wake during day et more sleep during night). In the first months of life, sleep episodes are frequently interrupted by wake, possibly induced by multiple external and internal stimuli. One of this stimulus could be bladder voiding that is particularly frequent in babies. Only one team worked on the link between sleep and bladder voiding and reported that bladder voiding was associated with cortical arousal during a daytime nap in a little group of babies.

In this study, investigators propose to study the relationship between sleep and bladder voiding in a bigger group of infant and during daytime but also nighttime sleep.

Eligibility

Sex
ALL
Min age
1 Month
Max age
12 Months
Healthy volunteers
No
Inclusion Criteria: * Infants of both sex * Age ≥1 month and ≤ 12 months * Referred to the sleep unit for sleep trouble screening following ALTE (Apparent Life Threatening Event). * Patients should benefit from appropriate insurance system * Parents who have expressed a willingness to participate in the study, who have signed and dated the informed consent. Exclusion Criteria: * Neurological, endocrinal or syndromic diseases : * Head and neck congenital malformations * Pierre Robin Syndrome * Trisomy * Achondroplasia * Prader Willy syndrome * Ondine syndrome * Cardiac diseases and malformations * Weight \<2.5 kg * Preterm babies (under 37 weeks of gestational age)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Service épilepsie, sommeil et explorations neuropédiatriques, Hôpital Femme mère enfant - Groupement hospitalier Est - HCL Bron France Recruiting

More Hospices Civils de Lyon trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04317677 on ClinicalTrials.gov ↗ ← All trials in France