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Effects of Bladder Voiding on Sleep Architecture in Infants (MIDESOM)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Enrolling

Conditions

Sleep

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04317677
69HCL18_0223

Details and patient eligibility

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.

Enrollment

30 estimated patients

Sex

All

Ages

1 to 12 months old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Babies hospitalized in the pediatric sleep unit
Other group
Treatment:
Other: Study of the effect of bladder voiding on sleep fragmentation during day and night sleep

Trial contacts and locations

1

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Central trial contact

Patricia FRANCO, Pr

Data sourced from clinicaltrials.gov

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