Sleep and Nocturnal Enuresis: Ambulatory Polysomnographic Study

NCT ID: NCT03477812

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-22
• Study Completion Date: 2020-12-31

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

Conditions

Nocturnal Enuresis; Polysomnography

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy children

Healthy children 7-14 years of age.

Polysomnography (Full sleep registration)

Intervention Type: DEVICE

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.

Polysomnography (Full sleep registration)

Intervention Type: DEVICE

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.

Polysomnography (Full sleep registration)

Intervention Type: DEVICE

For the healthy children two nights of polysomnography. For the children with nocturnal enuresis one night of polysomnography.

Interventions

Polysomnography (Full sleep registration)

For the healthy children two nights of polysomnography. For the children with nocturnal enuresis one night of polysomnography.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Søren Rittig, Professor

Role: STUDY_CHAIR

Aarhus University Hospital

Locations

Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital

Aarhus, Aarhus N, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Malthe Jessen Pedersen, Med. student

Role: CONTACT

maltpe@rm.dk

+45 22457047

Konstantinos Kamperis, Ass. prof.

Role: CONTACT

konskamp@rm.dk

+45 21644608

Facility Contacts

Søren Rittig, Professor

Role: primary

rittig@clin.au.dk

+45 20241005

Konstantinos Kamperis, Ass. prof.

Role: backup

konskamp@rm.dk

+45 21644608

References

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.

Reference Type: DERIVED

PMID: 36368073 (View on PubMed)

Other Identifiers

Sleep and nocturnal enuresis

Identifier Type: -

Identifier Source: org_study_id