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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy children | Healthy children 7-14 years of age. |
| |
| Nocturnal enuresis with polyuria | Children with nocturnal enuresis and polyuria aged 7-14 years. |
| |
| Nocturnal enuresis without polyuria | Children without nocturnal enuresis and polyuria aged 7-14 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polysomnography (Full sleep registration) | Device | For the healthy children two nights of polysomnography. For the children with nocturnal enuresis one night of polysomnography. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep efficiency | Sleep efficiency will be calculated as the ratio of the total time spent asleep to the total time spent in bed | One night of polysomnography. |
| Measure | Description | Time Frame |
|---|---|---|
| Periodic limb movements during sleep | Number of periodic limb movements per hour at sleep compared between the three groups. | One night of polysomnography. |
| Nocturnal urine production | We will compare the nocturnal urine production in millilitres in the three groups. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Malthe Jessen Pedersen, Med. student | Contact | +45 22457047 | maltpe@rm.dk | |
| Konstantinos Kamperis, Ass. prof. | Contact | +45 21644608 | konskamp@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Søren Rittig, Professor | Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital | Recruiting | Aarhus | Aarhus N | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36368073 | Derived | 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. |
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Individual participant data is not going to be available to other researchers.
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| ID | Term |
|---|---|
| D053206 | Nocturnal Enuresis |
| ID | Term |
|---|---|
| D004775 | Enuresis |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D017286 | Polysomnography |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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. | 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). | One night of polysomnography |
| Incidence of sleep disturbances | Percentage of children with clinical sleep disturbances between patients and controls | 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. | 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. | 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. | 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. | Two nights of polysomnography. Each evaluated after completing the two nights. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |