Sleep and Nocturnal Enuresis: Ambulatory Polysomnographic Study

Nocturnal Enuresis Clinical Trial

Official title: Sleep and Nocturnal Enuresis: Ambulatory Polysomnographic Study at Home - Differences Between Monosymptomatic Nocturnal Enuresis Patients and Healthy Controls

Status Recruiting

Clinical 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.

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis
• Polysomnography
• Urinary Incontinence

• NCT number: NCT03477812
• Study type: Observational
• Source: University of Aarhus
• Contact: Malthe Jessen Pedersen, Med. student
• Phone: +45 22457047
• Email: maltpe@rm.dk
• Status: Recruiting
• Start date: January 22, 2018
• Completion date: December 31, 2020