Effects of Bladder Voiding on Sleep Architecture in Infants

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Bladder Voiding on Sleep Architecture in Infants

Conditions
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Sleep

Intervention / Treatment
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* Other: Study of the effect of bladder voiding on sleep fragmentation during day and night sleep


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Babies hospitalized in the pediatric sleep unit<br> | Other: Study of the effect of bladder voiding on sleep fragmentation during day and night sleep<br>* Vigilance state of babies will be continuously recorded during the first 24 hours of hospitalization by polysomnography and actigraphy. In parallel, bladder voiding episodes will be detected with an innovative device placed on babies diapers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of arousals / awakenings in a timely relation with bladder voiding. | 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 | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep stage following bladder voiding events | 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. | 24 hours | 
| EEG frequencies following bladder voiding episodes | 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. | 24 hours | 
| Heart rate following bladder voiding episode | EKG will be obtained during the entire record. Investigators will determine the proportion of bladder voiding followed by a significant change of heart rate | 24 hours | 
| Activity record with actigraphy in babies | Coherence analysis between actigraphy and polysomnography records | 24 hours |