Nocturnal EnuresisNCT03477812
Sleep and Nocturnal Enuresis: Ambulatory Polysomnographic Study
An observational study of Nocturnal Enuresis and Polysomnography, run by University of Aarhus at 1 site in Denmark.
Trial summary
Full ambulatory polysomnography at home performed two nights in 30 healthy children and one night in 30 children with mono-symptomatic nocturnal enuresis (15 with polyuria and 15 without polyuria). The children will be aged 7-14 years of age. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Nocturnal Enuresis, Polysomnography
- What is being tested?
- Polysomnography (Full sleep registration)
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Jan 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will be 30 children with mono-symptomatic nocturnal enuresis aged from 7-14 years. The group of children with nocturnal enuresis will be split in two with 15 patients with polyuria and 15 without polyuria. The control group will be 30 healthy children aged 7-14 years of age.
Who may be able to join
- 7-14 years of age
- Normal objective evaluation including blood pressure
- For healthy controls achieved continence both day and night before the age of 5.
- For children with nocturnal enuresis at least 3 wet nights per week.
- For children with enuresis clinical characteristics and at least one week of home recordings of nocturnal urine production and two days of full recording of fluid intake and urine production.
Who cannot join
- Obstipation (according to ROM IV criteria)
- Day incontinence or severe urgency
- Insomnia or known sleep disorders such as sleep walking, heavy snoring, night terrors or abnormal circadian rhythm.
- Present or former deceases in the urinary tract, liver or in the endocrinological system.
- Hypertension
- Treatment with medication at the time of the study
- ADHD, autism or other psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital
Aarhus, Aarhus N, 8200
Søren Rittig, Professor, +45 20241005, rittig@clin.au.dk
Konstantinos Kamperis, Ass. prof., +45 21644608, konskamp@rm.dk
About this study
Official title: Sleep and Nocturnal Enuresis: Ambulatory Polysomnographic Study at Home - Differences Between Monosymptomatic Nocturnal Enuresis Patients and Healthy Controls
Full ambulatory polysomnography at home performed two nights in 30 healthy children and one night in 30 children with mono-symptomatic nocturnal enuresis (15 with polyuria and 15 without polyuria). The children will be aged 7-14 years of age.
The sleep will be evaluated on sleep quality, number of periodic limb movements per hour, blood pressure and pulse, beat to beat variation by electrocardiography during sleep, respiration during sleep, nocturnal urine production, and enuresis episodes.
Read the detailed description
Purpose and perspectives:
The purpose of the study is to investigate the quality of sleep, the sleep architecture and the intra-individual variation from night to night in healthy children and children with mono-symptomatic nocturnal enuresis (MNE) using full polysomnography at home.
Hypotheses:
- There is large intra-individual night to night variation in sleep quality and architecture.
- Children with MNE have different sleep architecture than healthy children when looking at sleep quality and arousals.
- Periodic limp movements at sleep is more frequent in children with MNE than in healthy children.
Design:
The study is a case-control study.
Materials and methods:
The study will recruit 30 healthy children and 30 children with MNE (15 with polyuria and 15 without polyuria) recruited from the Childrens Incontinence Center at the Department of Pediatrics and Adolescent Medicine at Aarhus University Hospital. Children of both sexes aged between 7 and 14 years of age will be enrolled. Children and their parents will be informed about the study both verbally and in written. Written informed consent from both parents must be obtained before the children can be enrolled in the study.
The healthy children will go through two nights of full polysomnography to be able to view intra-individual changes. The children with MNE will only have to do one night of polysomnography.
Primary parameters:
- Sleep quality
- Number of periodic limb movements per hour
- Blood pressure and pulse
- Beat to beat variation by electrocardiography during sleep
- Respiration during sleep
- Nocturnal urine production
- Enuresis episodes
- Conditions
- Nocturnal Enuresis, Polysomnography
- Being tested
- Polysomnography (Full sleep registration)
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polysomnography (Full sleep registration)Device
For the healthy children two nights of polysomnography. For the children with nocturnal enuresis one night of polysomnography.
| Study group | Role | What they receive |
|---|---|---|
| Healthy children | Healthy children 7-14 years of age. Receives: Device: Polysomnography (Full sleep registration) | |
| Nocturnal enuresis with polyuria | Children with nocturnal enuresis and polyuria aged 7-14 years. Receives: Device: Polysomnography (Full sleep registration) | |
| Nocturnal enuresis without polyuria | Children without nocturnal enuresis and polyuria aged 7-14 years. Receives: Device: Polysomnography (Full sleep registration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency
Sleep efficiency will be calculated as the ratio of the total time spent asleep to the total time spent in bed
Measured: One night of polysomnography.
Secondary outcomes (9)
Periodic limb movements during sleep
Number of periodic limb movements per hour at sleep compared between the three groups.
Measured: One night of polysomnography.
Nocturnal urine production
We will compare the nocturnal urine production in millilitres in the three groups.
Measured: One night of polysomnography.
Enuresis episodes
We are going to look at the time of the enuresis episode and compare it to the polysomnographic findings at that time.
Measured: One night of polysomnography
Respiratory events during sleep
Respiration during sleep comparison between the three groups. This includes saturation, nasal air flow and movement of the stomach and chest. Together showing the number of respiratory events (apneas/hour).
Measured: One night of polysomnography
Incidence of sleep disturbances
Percentage of children with clinical sleep disturbances between patients and controls
Measured: One night of polysomnography
Intra-individual differences in sleep efficiency from night to night in healthy controls.
Sleep efficiency (in percent) will be compared between the two nights of polysomnography in the healthy controls.
Measured: Two nights of polysomnography. Each evaluated after completing the two nights.
Intra-individual differences in periodic limb movements during sleep from night to night in healthy controls.
Periodic limb movements during sleep will be compared between the two nights of polysomnography in the healthy controls.
Measured: Two nights of polysomnography. Each evaluated after completing the two nights.
Intra-individual differences in nocturnal urine production from night to night in healthy controls.
Nocturnal urine production will be compared between the two study nights in the healthy controls.
Measured: Two nights of polysomnography. Each evaluated after completing the two nights.
Intra-individual differences in respiratory events from night to night in healthy controls.
The number and kinds of respiratory events will be compared between the two study nights in the healthy controls.
Measured: Two nights of polysomnography. Each evaluated after completing the two nights.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start22 Jan 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nocturnal EnuresisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Søren Rittig, Professor, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477812
- Sponsor's protocol ID
- Sleep and nocturnal enuresis
- Status last verified
- Jan 2018
- First submitted
- 5 Feb 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data is not going to be available to other researchers.
Publications
Pedersen MJ, Leonthin H, Mahler B, Rittig S, Jennum PJ, Kamperis K. Two nights of home polysomnography in healthy 7-14-year-old children - Feasibility and intraindividual variability. Sleep Med. 2023 Jan;101:87-92. doi: 10.1016/j.sleep.2022.10.027. Epub 2022 Oct 30.
PubMed 36368073
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Nocturnal Enuresis: Ambulatory Polysomnographic Study at Home - Differences Between Monosymptomatic Nocturnal Enuresis Patients and Healthy Controls
- ClinicalTrials.gov ID
- NCT03477812
- Acronym / sponsor ID
- Sleep and nocturnal enuresis
- Conditions
- Nocturnal Enuresis, Polysomnography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 26 Mar 2018 (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.
Full ambulatory polysomnography at home performed two nights in 30 healthy children and one night in 30 children with mono-symptomatic nocturnal enuresis (15 with polyuria and 15 without polyuria). The children will be aged 7-14 years of age.
The sleep will be evaluated on sleep quality, number of periodic limb movements per hour, blood pressure and pulse, beat to beat variation by electrocardiography during sleep, respiration during sleep, nocturnal urine production, and enuresis episodes.
Detailed description
Purpose and perspectives:
The purpose of the study is to investigate the quality of sleep, the sleep architecture and the intra-individual variation from night to night in healthy children and children with mono-symptomatic nocturnal enuresis (MNE) using full polysomnography at home.
Hypotheses:
- There is large intra-individual night to night variation in sleep quality and architecture.
- Children with MNE have different sleep architecture than healthy children when looking at sleep quality and arousals.
- Periodic limp movements at sleep is more frequent in children with MNE than in healthy children.
Design:
The study is a case-control study.
Materials and methods:
The study will recruit 30 healthy children and 30 children with MNE (15 with polyuria and 15 without polyuria) recruited from the Childrens Incontinence Center at the Department of Pediatrics and Adolescent Medicine at Aarhus University Hospital. Children of both sexes aged between 7 and 14 years of age will be enrolled. Children and their parents will be informed about the study both verbally and in written. Written informed consent from both parents must be obtained before the children can be enrolled in the study.
The healthy children will go through two nights of full polysomnography to be able to view intra-individual changes. The children with MNE will only have to do one night of polysomnography.
Primary parameters:
- Sleep quality
- Number of periodic limb movements per hour
- Blood pressure and pulse
- Beat to beat variation by electrocardiography during sleep
- Respiration during sleep
- Nocturnal urine production
- Enuresis episodes
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy children | – | Device: Polysomnography (Full sleep registration)Healthy children 7-14 years of age. |
| Nocturnal enuresis with polyuria | – | Device: Polysomnography (Full sleep registration)Children with nocturnal enuresis and polyuria aged 7-14 years. |
| Nocturnal enuresis without polyuria | – | Device: Polysomnography (Full sleep registration)Children without nocturnal enuresis and polyuria aged 7-14 years. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will be 30 children with mono-symptomatic nocturnal enuresis aged from 7-14 years. The group of children with nocturnal enuresis will be split in two with 15 patients with polyuria and 15 without polyuria. The control group will be 30 healthy children aged 7-14 years of age.
Key inclusion criteria (5 listed)
- 7-14 years of age
- Normal objective evaluation including blood pressure
- For healthy controls achieved continence both day and night before the age of 5.
- For children with nocturnal enuresis at least 3 wet nights per week.
- For children with enuresis clinical characteristics and at least one week of home recordings of nocturnal urine production and two days of full recording of fluid intake and urine production.
Key exclusion criteria (7 listed)
- Obstipation (according to ROM IV criteria)
- Day incontinence or severe urgency
- Insomnia or known sleep disorders such as sleep walking, heavy snoring, night terrors or abnormal circadian rhythm.
- Present or former deceases in the urinary tract, liver or in the endocrinological system.
- Hypertension
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 |
|---|---|---|
| Polysomnography (Full sleep registration)For the healthy children two nights of polysomnography. For the children with nocturnal enuresis one night of polysomnography. | Device | Healthy children, Nocturnal enuresis with polyuria, Nocturnal enuresis without polyuria |
Primary outcome
Sleep efficiency
Time frame: One night of polysomnography.
Sleep efficiency will be calculated as the ratio of the total time spent asleep to the total time spent in bed
9 secondary outcomes
Periodic limb movements during sleep
Time frame: One night of polysomnography.
Nocturnal urine production
Time frame: One night of polysomnography.
Enuresis episodes
Time frame: One night of polysomnography
Respiratory events during sleep
Time frame: One night of polysomnography
Incidence of sleep disturbances
Time frame: One night of polysomnography
Intra-individual differences in sleep efficiency from night to night in healthy controls.
Time frame: Two nights of polysomnography. Each evaluated after completing the two nights.
Intra-individual differences in periodic limb movements during sleep from night to night in healthy controls.
Time frame: Two nights of polysomnography. Each evaluated after completing the two nights.
Intra-individual differences in nocturnal urine production from night to night in healthy controls.
Time frame: Two nights of polysomnography. Each evaluated after completing the two nights.
Intra-individual differences in respiratory events from night to night in healthy controls.
Time frame: Two nights of polysomnography. Each evaluated after completing the two nights.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Derived from this study: PubMed 36368073Pedersen MJ, Leonthin H, Mahler B, Rittig S, Jennum PJ, Kamperis K. Two nights of home polysomnography in healthy 7-14-year-old children - Feasibility and intraindividual variability. Sleep Med. 2023 Jan;101:87-92. doi: 10.1016/j.sleep.2022.10.027. Epub 2022 Oct 30.
- Individual participant dataSharing planned: No. Individual participant data is not going to be available to other researchers.
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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. This study is not recruiting at the moment.
Søren Rittig, Professor study chair
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nocturnal Enuresis and Polysomnography, run by University of Aarhus at 1 site in Denmark.
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 7 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: status not confirmed, as of the sponsor's last update on 5 Apr 2018. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Malthe Jessen Pedersen, Med. student (+45 22457047, maltpe@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency (time frame: One night of polysomnography.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03477812, which also lists 1 linked publication.
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 5 Apr 2018.