Sleep and Nocturnal Enuresis: Ambulatory Polysomnographic Study

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

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.

Study Overview

• Status: Unknown
• Conditions: Nocturnal Enuresis; Polysomnography
• Intervention / Treatment: Device: Polysomnography (Full sleep registration)

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

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N
    • Aarhus, Aarhus N, Denmark, 8200
      • Recruiting
      • Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital
      • Contact: Konstantinos Kamperis, Ass. prof.; Phone Number: +45 21644608; Email: konskamp@rm.dk
      • Contact: Søren Rittig, Professor; Phone Number: +45 20241005; Email: rittig@clin.au.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy children; Healthy children 7-14 years of age.	Device: Polysomnography (Full sleep registration); For the healthy children two nights of polysomnography. For the children with nocturnal enuresis one night of polysomnography.
Nocturnal enuresis with polyuria; Children with 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.
Nocturnal enuresis without polyuria; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Study Chair: Søren Rittig, Professor, Aarhus University Hospital

Publications and helpful links

General Publications

• 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. 2022 Oct 30;101:87-92. doi: 10.1016/j.sleep.2022.10.027. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Nocturnal Enuresis
• Other Study ID Numbers: Sleep and nocturnal enuresis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data is not going to be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No