An observational study in Nocturnal Enuresis and Polysomnography, sponsored by University of Aarhus. Status unknown at 1 site in Denmark. Open to participants aged 7 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by University of Aarhus · Observational
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Among 12 studies in Nocturnal Enuresis with a site in Denmark — 3 open to participants now, 3 under way, none of them phase 3. Nocturnal Enuresis · Denmark.
Among the 12 studies in Nocturnal Enuresis with a site in Denmark, this one is the only one that started in 2018, is one of 2 observational ones, and was the 5th registered.
105 studies on the registry are indexed under Nocturnal Enuresis; 22 are open to participants now.
Browse Nocturnal Enuresis studies →3 of the 12 studies in Nocturnal Enuresis with a site in Denmark are open now. Recruiting first, the newest first:
InnoCon Medical · Sites in Denmark
Ages 18+
InnoCon Medical · Sites in Denmark
Ages 18+ · Women only
Aalborg University Hospital · Sites in Denmark
Ages 6–14 · Healthy volunteers
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 14 Nocturnal Enuresis studies recruiting now, 5 (36%) set no upper age limit and 9 (64%) stop at 75 or younger; 8 take children under 18; 2 take healthy volunteers.
This study: 7 Years to 14 Years · all sexes · healthy volunteers too.
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12 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 100 across 24 observational studies indexed under Nocturnal Enuresis.
Median enrollment 65 across the 10 interventional studies, 52 across the 2 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
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3 of 12 have an industry lead sponsor. The 3 most frequent:
University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
University of Aarhus has 7 studies filed under Nocturnal Enuresis — fewer than ten, so there is no comparison to draw.
1 of the studies in Nocturnal Enuresis with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06091566InnoCon MedicalSafety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) | 2027-01-01 |
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Among the 12 studies in Nocturnal Enuresis with a site in Denmark, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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:
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:
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.
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Exclusion Criteria:
Healthy children 7-14 years of age.
Device: Polysomnography (Full sleep registration)
Children with nocturnal enuresis and polyuria aged 7-14 years.
Device: Polysomnography (Full sleep registration)
Children without nocturnal enuresis and polyuria aged 7-14 years.
Device: Polysomnography (Full sleep registration)
For the healthy children two nights of polysomnography. For the children with nocturnal enuresis one night of polysomnography.
Sleep efficiency
Sleep efficiency will be calculated as the ratio of the total time spent asleep to the total time spent in bed
Time frame: One night of polysomnography.
Periodic limb movements during sleep
Number of periodic limb movements per hour at sleep compared between the three groups.
Time frame: One night of polysomnography.
Nocturnal urine production
We will compare the nocturnal urine production in millilitres in the three groups.
Time frame: 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.
Time frame: 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).
Time frame: One night of polysomnography
Incidence of sleep disturbances
Percentage of children with clinical sleep disturbances between patients and controls
Time frame: 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.
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.
Periodic limb movements during sleep will be compared between the two nights of polysomnography in the 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.
Nocturnal urine production will be compared between the two study nights in the 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.
The number and kinds of respiratory events will be compared between the two study nights in the healthy controls.
Time frame: Two nights of polysomnography. Each evaluated after completing the two nights.
Plan to share: No — Individual participant data is not going to be available to other researchers.
Started Jan 2018 (actual). Primary completion is estimated for Dec 2020, 35 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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