Actively Recruiting

Phase Not Applicable
Age: 1Month - 12Months
All Genders
NCT04317677

Effects of Bladder Voiding on Sleep Architecture in Infants

Led by Hospices Civils de Lyon · Updated on 2025-01-30

30

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effects of Bladder Voiding on Sleep Architecture in Infants

Who Can Participate

Age: 1Month - 12Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants of both sexes
  • Age between 1 month and 12 months
  • Referred to the sleep unit for sleep trouble screening following Apparent Life Threatening Event (ALTE)
  • Patients should have appropriate insurance coverage
  • Parents or guardians have signed and dated the informed consent to participate
Not Eligible

You will not qualify if you...

  • Presence of neurological, endocrinal, or syndromic diseases including:
    • Head and neck congenital malformations
    • Pierre Robin Syndrome
    • Trisomy
    • Achondroplasia
    • Prader Willy syndrome
    • Ondine syndrome
    • Cardiac diseases and malformations
  • Weight less than 2.5 kilograms
  • Premature babies born before 37 weeks of gestational age

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Bron, France, 69500

Actively Recruiting

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Research Team

P

Patricia FRANCO, Pr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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