SleepMIDESOMNCT04317677
Effects of Bladder Voiding on Sleep Architecture in Infants
A study testing Study of the effect of bladder voiding on sleep fragmentation during day and night sleep in people with Sleep, run by Hospices Civils de Lyon at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Sleep
- What is being tested?
- Study of the effect of bladder voiding on sleep fragmentation during day and night sleep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2020to 9 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Neurological, endocrinal or syndromic diseases :
- Head and neck congenital malformations
- Pierre Robin Syndrome
- Trisomy
- Achondroplasia
- Prader Willy syndrome
Show all 10Show fewer
- Ondine syndrome
- Cardiac diseases and malformations
- Weight <2.5 kg
- Preterm babies (under 37 weeks of gestational age)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service épilepsie, sommeil et explorations neuropédiatriques, Hôpital Femme mère enfant - Groupement hospitalier Est - HCL
Bron, 69500
Patricia FRANCO, MD, PhD, 04.27.85.60.52 ext. +33, patricia.franco@chu-lyon.fr
Patricia FRANCO, MD, PhD
About this study
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
- Being tested
- Study of the effect of bladder voiding on sleep fragmentation during day and night sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of the effect of bladder voiding on sleep fragmentation during day and night sleepOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Babies hospitalized in the pediatric sleep unit | Other | Not described Receives: Other: Study of the effect of bladder voiding on sleep fragmentation during day and night sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 24 hours
Activity record with actigraphy in babies
Coherence analysis between actigraphy and polysomnography records
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start9 Dec 2020
- Primary completion9 Dec 2025 (estimated)
- Study completion9 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317677
- Sponsor's protocol ID
- 69HCL18_0223
- Acronym
- MIDESOM
- Status last verified
- Jan 2025
- First submitted
- 19 Mar 2020
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bladder Voiding on Sleep Architecture in Infants
- ClinicalTrials.gov ID
- NCT04317677
- Acronym / sponsor ID
- MIDESOM / 69HCL18_0223
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 9 Dec 2025 (estimated)
- Study completion
- 9 Dec 2025 (estimated)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Babies hospitalized in the pediatric sleep unit | Other | Other: Study of the effect of bladder voiding on sleep fragmentation during day and night sleep |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- Neurological, endocrinal or syndromic diseases :
- Weight <2.5 kg
- Preterm babies (under 37 weeks of gestational age)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study of the effect of bladder voiding on sleep fragmentation during day and night sleepVigilance 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. | Other | Babies hospitalized in the pediatric sleep unit |
Primary outcome
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
4 secondary outcomes
Sleep stage following bladder voiding events
Time frame: 24 hours
EEG frequencies following bladder voiding episodes
Time frame: 24 hours
Heart rate following bladder voiding episode
Time frame: 24 hours
Activity record with actigraphy in babies
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study of the effect of bladder voiding on sleep fragmentation during day and night sleep in people with Sleep, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia FRANCO, Pr (04.27.85.60.52 ext. +33, patricia.franco@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of arousals / awakenings in a timely relation with bladder voiding. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.