Effects of Bladder Voiding on Sleep Architecture in Infants (MIDESOM)

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep
• Intervention / Treatment: Other: Study of the effect of bladder voiding on sleep fragmentation during day and night sleep

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia FRANCO, Pr; Phone Number: +33 04.27.85.60.52; Email: patricia.franco@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Service épilepsie, sommeil et explorations neuropédiatriques, Hôpital Femme mère enfant - Groupement hospitalier Est - HCL
    • Contact: Patricia FRANCO, MD, PhD; Phone Number: +33 04.27.85.60.52; Email: patricia.franco@chu-lyon.fr
    • Contact: Patricia FRANCO, MD, PhD
    • Contact: Anne GUIGNARD PERRET, MD
    • Contact: Aude RAOUX, MD
    • Contact: Béatrice KUGENER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Babies hospitalized in the pediatric sleep unit	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep stage following bladder voiding events	Sleep stages will be scored as defined by the international rules (AASM 2007). Investigators will determine the proportion of bladder voiding events leading to a change of sleep stage.	24 hours
EEG frequencies following bladder voiding episodes	EEG will be quantitatively analyzed and the power spectrum in each frequency band will be determined. Investigators will determine the proportion of bladder voiding events followed by a significant change of EEG frequencies.	24 hours
Heart rate following bladder voiding episode	EKG will be obtained during the entire record. Investigators will determine the proportion of bladder voiding followed by a significant change of heart rate	24 hours
Activity record with actigraphy in babies	Coherence analysis between actigraphy and polysomnography records	24 hours

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2020
• Primary Completion (Estimated): December 9, 2025
• Study Completion (Estimated): December 9, 2025

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 69HCL18_0223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No