Effects of Bladder Voiding on Sleep Architecture in Infants

Sleep Clinical Trial

— MIDESOM  

Official title:

Effects of Bladder Voiding on Sleep Architecture in Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04317677
• Other study ID #: 69HCL18_0223
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2020
• Est. completion date: December 9, 2022

Study information

• Verified date: December 2020
• Source: Hospices Civils de Lyon
• Contact: Patricia FRANCO, Pr
• Phone: 04.27.85.60.52
• Email: patricia.franco[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 9, 2022
• Est. primary completion date: December 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 12 Months

Eligibility

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)

Related Conditions & MeSH terms

• Sleep

Intervention

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.

Locations

Country	Name	City	State
France	Service épilepsie, sommeil et explorations neuropédiatriques, Hôpital Femme mère enfant - Groupement hospitalier Est - HCL	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Activity record with actigraphy in babies	Coherence analysis between actigraphy and polysomnography records	24 hours