Effects of Bladder Voiding on Sleep Architecture in Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Study of the effect of bladder voiding on sleep fragmentation during day and night sleep.
- Who it may be relevant to
- Registry conditions: Sleep. Basic parameters: 1 months — 12 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Study 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.
Primary outcome measures
- Occurrence of arousals / awakenings in a timely relation with bladder voiding. [Time frame: 24 hours]
Secondary outcome measures (4)
- Sleep stage following bladder voiding events [Time frame: 24 hours]
- EEG frequencies following bladder voiding episodes [Time frame: 24 hours]
- Heart rate following bladder voiding episode [Time frame: 24 hours]
- Activity record with actigraphy in babies [Time frame: 24 hours]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- Service épilepsie, sommeil et explorations neuropédiatriques, Hôpital Femme mère enfant - — Bron
Identifiers
NCT: NCT04317677 · 69HCL18_0223