Status:

RECRUITING

Effects of Bladder Voiding on Sleep Architecture in Infants

Lead Sponsor:

Hospices Civils de Lyon

Conditions:

Sleep

Eligibility:

All Genders

1-12 years

Phase:

NA

Brief 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 organ...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

December 9 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 9 2025

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04317677

Start Date

December 9 2020

End Date

December 9 2025

Last Update

January 30 2025

Active Locations (1)

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

Bron, France, 69500