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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03477812
• Other study ID #: Sleep and nocturnal enuresis
• Status: Recruiting
• First received: February 5, 2018
• Last updated: April 3, 2018
• Start date: January 22, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2018
• Source: University of Aarhus
• Contact: Malthe Jessen Pedersen, Med. student
• Phone: +45 22457047
• Email: maltpe[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis
• Polysomnography
• Urinary Incontinence

Intervention

Device:
• Polysomnography (Full sleep registration)
For the healthy children two nights of polysomnography. For the children with nocturnal enuresis one night of polysomnography.

Locations

Country	Name	City	State
Denmark	Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital	Aarhus	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Periodic limb movements during sleep	Number of periodic limb movements per hour at sleep compared between the three groups.	One night of polysomnography.
Secondary	Nocturnal urine production	We will compare the nocturnal urine production in millilitres in the three groups.	One night of polysomnography.
Secondary	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
Secondary	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
Secondary	Incidence of sleep disturbances	Percentage of children with clinical sleep disturbances between patients and controls	One night of polysomnography
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.