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NCT Number: NCT04317677

Effects of Bladder Voiding on Sleep Architecture in Infants

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.

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Key information

Conditions

Sleep

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bron, 69500, France

Location status: Recruiting

Location contact

Anne GUIGNARD PERRET, MD

SUB_INVESTIGATOR

Aude RAOUX, MD

SUB_INVESTIGATOR

Béatrice KUGENER, MD

SUB_INVESTIGATOR

Patricia FRANCO, MD, PhD

CONTACT

[email protected]

04.27.85.60.52 ext. +33

Patricia FRANCO, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 24 hours

    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

Secondary outcomes

  1. Sleep stage following bladder voiding events

    Time frame: 24 hours

    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.

  2. EEG frequencies following bladder voiding episodes

    Time frame: 24 hours

    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.

  3. Heart rate following bladder voiding episode

    Time frame: 24 hours

    EKG will be obtained during the entire record. Investigators will determine the proportion of bladder voiding followed by a significant change of heart rate

  4. Activity record with actigraphy in babies

    Time frame: 24 hours

    Coherence analysis between actigraphy and polysomnography records

Study contacts

Contact information is provided by the study sponsor or research team.

Patricia FRANCO, Pr

CONTACT

[email protected]

04.27.85.60.52 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: MIDESOM

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Mar 23, 2020
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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