Sleep and Nocturnal Enuresis: Ambulatory Polysomnographic Study

April 3, 2018 updated by: University of Aarhus

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Malthe Jessen Pedersen, Med. student
  • Phone Number: +45 22457047
  • Email: maltpe@rm.dk

Study Contact Backup

  • Name: Konstantinos Kamperis, Ass. prof.
  • Phone Number: +45 21644608
  • Email: konskamp@rm.dk

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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sleep efficiency
Time Frame: One night of polysomnography.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Periodic limb movements during sleep
Time Frame: One night of polysomnography.
Number of periodic limb movements per hour at sleep compared between the three groups.
One night of polysomnography.
Nocturnal urine production
Time Frame: One night of polysomnography.
We will compare the nocturnal urine production in millilitres in the three groups.
One night of polysomnography.
Enuresis episodes
Time Frame: One night of polysomnography
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
Time Frame: One night of polysomnography
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
Time Frame: One night of polysomnography
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.
Time Frame: Two nights of polysomnography. Each evaluated after completing the two nights.
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.
Time Frame: Two nights of polysomnography. Each evaluated after completing the two nights.
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.
Time Frame: Two nights of polysomnography. Each evaluated after completing the two nights.
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.
Time Frame: Two nights of polysomnography. Each evaluated after completing the two nights.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Søren Rittig, Professor, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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