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Effects of Bladder Voiding on Sleep Architecture in Infants

RecruitingNAAges 1 Month - 12 MonthsAllHospices Civils de Lyon
NCT04317677 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

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

1 site
Service épilepsie, sommeil et explorations neuropédiatriques, Hôpital Femme mère enfant - Groupement hospitalier Est - HCL
Bron, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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