Effects of Bladder Voiding on Sleep Architecture in Infants (NCT04317677) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Bladder Voiding on Sleep Architecture in Infants
France30 participantsStarted 2020-12-09
Plain-language 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.
Who can participate
Age range
1 Month – 12 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of arousals / awakenings in a timely relation with bladder voiding.