Investigating how bladder voiding affects sleep in infants
Effects of Bladder Voiding on Sleep Architecture in Infants
NA · Hospices Civils de Lyon · NCT04317677
This study is testing if how often babies pee affects their sleep patterns to help improve sleep quality for infants aged 1 to 12 months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 1 Month to 12 Months |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Locations | 1 site (Bron) |
| Trial ID | NCT04317677 on ClinicalTrials.gov |
What this trial studies
This study examines the relationship between bladder voiding and sleep patterns in infants aged 1 to 12 months. It aims to understand how bladder voiding may contribute to sleep fragmentation during both daytime and nighttime sleep. By analyzing a larger group of infants referred for sleep trouble screening, the study seeks to build on previous findings that suggested a link between bladder voiding and cortical arousal during naps. The goal is to provide insights that could improve sleep quality in infants.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 1 to 12 months who are experiencing sleep troubles and have been referred for screening.
Not a fit: Patients with significant neurological, endocrinal, or syndromic diseases, as well as preterm infants, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management of sleep issues in infants, enhancing their overall sleep quality.
How similar studies have performed: Previous studies have suggested a link between bladder voiding and sleep disruption, but this study aims to explore this relationship in a larger cohort, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bron
- Service épilepsie, sommeil et explorations neuropédiatriques, Hôpital Femme mère enfant - Groupement hospitalier Est - HCL — Bron, France (RECRUITING)
Study contacts
- Study coordinator: Patricia FRANCO, Pr
- Email: patricia.franco@chu-lyon.fr
- Phone: 04.27.85.60.52
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep