Effects of Bladder Voiding on Sleep Architecture in Infants

NCT04317677 | Recruiting

• 1 other identifier: 69HCL18_0223
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Occurrence of arousals / awakenings in a timely relation with bladder voiding.

  The 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

  24 hours

Secondary Outcomes (4)

• Sleep stage following bladder voiding events

  24 hours

• EEG frequencies following bladder voiding episodes

  24 hours

• Heart rate following bladder voiding episode

  24 hours

• Activity record with actigraphy in babies

  24 hours

Study Arms (1)

Babies hospitalized in the pediatric sleep unit

OTHER

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

Interventions

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

Babies hospitalized in the pediatric sleep unit

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69500, France

RECRUITING

Central Study Contacts

Patricia FRANCO, Pr

CONTACT

04.27.85.60.52; patricia.franco@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 23, 2020
• Study Start: December 9, 2020
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)