Clinical trial NCT03477812: Sleep and Nocturnal Enuresis: Ambulatory Polysomnographic Study
Official title: Sleep and Nocturnal Enuresis: Ambulatory Polysomnographic Study at Home - Differences Between Monosymptomatic Nocturnal Enuresis Patients and Healthy Controls
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nocturnal Enuresis
Polysomnography
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Sleep efficiency
timeFrame: One night of polysomnography.
Secondary outcomes:
measure: Periodic limb movements during sleep
timeFrame: One night of polysomnography.
measure: Nocturnal urine production
timeFrame: One night of polysomnography.
measure: Enuresis episodes
timeFrame: One night of polysomnography
measure: Respiratory events during sleep
timeFrame: One night of polysomnography
measure: Incidence of sleep disturbances
timeFrame: One night of polysomnography
measure: Intra-individual differences in sleep efficiency from night to night in healthy controls.
timeFrame: Two nights of polysomnography. Each evaluated after completing the two nights.
measure: Intra-individual differences in periodic limb movements during sleep from night to night in healthy controls.
timeFrame: Two nights of polysomnography. Each evaluated after completing the two nights.
measure: Intra-individual differences in nocturnal urine production from night to night in healthy controls.
timeFrame: Two nights of polysomnography. Each evaluated after completing the two nights.
measure: Intra-individual differences in respiratory events from night to night in healthy controls.
timeFrame: Two nights of polysomnography. Each evaluated after completing the two nights.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital
state: Aarhus N
Study officials:
affiliation: Aarhus University Hospital
name: Søren Rittig, Professor
role: STUDY_CHAIR
References:
citation: 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.