Sleep and Nocturnal Enuresis: Ambulatory Polysomnographic Study

NCT03477812 | Unknown DMC

• 1 other identifier: Sleep and nocturnal enuresis
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Nocturnal Enuresis; Polysomnography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Periodic limb movements during sleep

  One night of polysomnography.

• Nocturnal urine production

  One night of polysomnography.

• Enuresis episodes

  One night of polysomnography

• Respiratory events during sleep

  One night of polysomnography

• Incidence of sleep disturbances

  One night of polysomnography

Study Arms (3)

Healthy children

Healthy children 7-14 years of age.

Device: Polysomnography (Full sleep registration)

Nocturnal enuresis with polyuria

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

Device: Polysomnography (Full sleep registration)

Nocturnal enuresis without polyuria

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

Device: Polysomnography (Full sleep registration)

Interventions

Polysomnography (Full sleep registration) DEVICE

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

Healthy children; Nocturnal enuresis with polyuria; Nocturnal enuresis without polyuria

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 36368073 DERIVED

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Søren Rittig, Professor

  Aarhus University Hospital

  STUDY CHAIR

Central Study Contacts

Malthe Jessen Pedersen, Med. student

CONTACT

+45 22457047; maltpe@rm.dk

Konstantinos Kamperis, Ass. prof.

CONTACT

+45 21644608; konskamp@rm.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: March 26, 2018
• Study Start: January 22, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)