Sleep and Nocturnal Enuresis: Ambulatory Polysomnographic Study

University of Aarhus

Status: Unknown

Conditions: Polysomnography; Nocturnal Enuresis

Treatments: Device: Polysomnography (Full sleep registration)

Study type: Observational

Funder types: Other

Identifiers

NCT03477812

Sleep and nocturnal enuresis

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 7 to 14 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

60 participants in 3 patient groups

Healthy children

Description:

Healthy children 7-14 years of age.

Treatment:

Device: Polysomnography (Full sleep registration)

Nocturnal enuresis with polyuria

Description:

Children with nocturnal enuresis and polyuria aged 7-14 years.

Treatment:

Device: Polysomnography (Full sleep registration)

Nocturnal enuresis without polyuria

Description:

Children without nocturnal enuresis and polyuria aged 7-14 years.

Treatment:

Device: Polysomnography (Full sleep registration)