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Effects of Bladder Voiding on Sleep Architecture in Infants

Effects of Bladder Voiding on Sleep Architecture in Infants

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04317677
Acronym
MIDESOM
Enrollment
30
Registered
2020-03-23
Start date
2020-12-09
Completion date
2025-12-09
Last updated
2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

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.

Interventions

OTHERStudy of the effect of bladder voiding on sleep fragmentation during day and night sleep

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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 12 Months
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of arousals / awakenings in a timely relation with bladder voiding.24 hoursThe 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

MeasureTime frameDescription
Sleep stage following bladder voiding events24 hoursSleep 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.
EEG frequencies following bladder voiding episodes24 hoursEEG 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.
Heart rate following bladder voiding episode24 hoursEKG will be obtained during the entire record. Investigators will determine the proportion of bladder voiding followed by a significant change of heart rate
Activity record with actigraphy in babies24 hoursCoherence analysis between actigraphy and polysomnography records

Countries

France

Contacts

Primary ContactPatricia FRANCO, Pr
patricia.franco@chu-lyon.fr04.27.85.60.52

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026