Effects of Bladder Voiding on Sleep Architecture in Infants

NCT ID: NCT04317677

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-09
• Study Completion Date: 2025-12-09

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.

Conditions

Sleep

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Babies hospitalized in the pediatric sleep unit

Group Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service épilepsie, sommeil et explorations neuropédiatriques, Hôpital Femme mère enfant - Groupement hospitalier Est - HCL

Bron, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Patricia FRANCO, Pr

Role: CONTACT

patricia.franco@chu-lyon.fr

04.27.85.60.52 ext. +33

Facility Contacts

Patricia FRANCO, MD, PhD

Role: primary

patricia.franco@chu-lyon.fr

04.27.85.60.52 ext. +33

Other Identifiers

69HCL18_0223

Identifier Type: -

Identifier Source: org_study_id