Effects of Bladder Voiding on Sleep Architecture in Infants

Not Applicable

• Conditions: Sleep
• Interventions: Other: Study of the effect of bladder voiding on sleep fragmentation during day and night sleep

• Registration Number: NCT04317677
• Lead Sponsor: Hospices Civils de Lyon

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-23
• Status Verified: 2020-12
• Study Start: 2020-12-09
• Last Update Submitted: 2020-12-21
• Last Update Posted: 2020-12-22
• Primary Completion: 2022-12-09
• Study Completion: 2022-12-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Babies hospitalized in the pediatric sleep unit	Study of the effect of bladder voiding on sleep fragmentation during day and night sleep	-

Primary Outcome Measures

Name	Time	Method
Occurrence of arousals / awakenings in a timely relation with bladder voiding.	24 hours	The occurrence of arousals and awakenings will be determined form polysomnography signals including electroencephalogram (EEG), electrooculogram (EOG) and a electromyogram (EMG). Arousals and awakenings will be scored as defined by the international rules for visual scoring of EEG (AASM manual 2007). Investigators will calculate the percentage of bladder voiding episode leading to arousal / awakening events

Secondary Outcome Measures

Name	Time	Method
Sleep stage following bladder voiding events	24 hours	Sleep stages will be scored as defined by the international rules (AASM 2007). Investigators will determine the proportion of bladder voiding events leading to a change of sleep stage.
Activity record with actigraphy in babies	24 hours	Coherence analysis between actigraphy and polysomnography records
Heart rate following bladder voiding episode	24 hours	EKG will be obtained during the entire record. Investigators will determine the proportion of bladder voiding followed by a significant change of heart rate
EEG frequencies following bladder voiding episodes	24 hours	EEG will be quantitatively analyzed and the power spectrum in each frequency band will be determined. Investigators will determine the proportion of bladder voiding events followed by a significant change of EEG frequencies.

Trial Locations

Locations (1)

Service épilepsie, sommeil et explorations neuropédiatriques, Hôpital Femme mère enfant - Groupement hospitalier Est - HCL; 🇫🇷 Bron, France