Desmopressin Melt: Impact on Sleep and Daytime Functioning (SLEEP)

December 13, 2022 updated by: University Hospital, Ghent

Desmopressin Melt: Impact on Sleep and Daytime Functioning? A Prospective Study.

Nocturnal enuresis affects 10% of the 7-year-old children and is essentially caused by a mismatch between nocturnal bladder capacity and the amount of urine produced during the night together with failure of the child to awaken in response to a full bladder.Urine overproduction at night or nocturnal polyuria (NP) is a major factor contributing to monosymptomatic nocturnal enuresis (MNE) pathophysiology in a large proportion of patients.

Since NP is related to an abnormal circadian rhythm of arginine vasopressin (AVP) secretion, the synthetic AVP analogue desmopressin is widely used to treat MNE.

It is recommended by the International Consultation on Incontinence (grade A,level 1). Desmopressin is available in 3 different formulations: nasal spray, tablet and the newest form melt.

Baeyens et al demonstrated an increased prevalence of attention deficit-hyperactivity disorder (ADHD) in children with MNE According to recent data there is a high incidence of periodic limb movements in sleep at night in children with nocturnal enuresis. Those children have an increased cortical arousability leading to awakening.

The frequent awakening most likely has an influence on concentration and other ADHD-symptoms in daily life.

This study will assess the impact of desmopressin melt on prepulse inhibition, ADHD-symptoms, cognition and learning, sleep, quality of life and self esteem.

New patients aged 6-16 years with monosymptomatic nocturnal enuresis, nocturnal polyuria and sleep problems are tested before the start of the study medication desmopressin melt (T1) and 6 months later (T2). It is a multi-method, multi-informant study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University Hospital

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

Ages Eligible for Study

4 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • New patient
  • age 6 to 16 years
  • monosymptomatic nocturnal enuresis, nocturnal polyuria and sleep problems

Exclusion Criteria:

  • mental retardation
  • autism spectrum disorders
  • daytime incontinence resistant to therapy
  • dysfunctional voiding
  • poor therapy-compliance
  • diuretics, antihypertensives, uropathy, renal abnormalities

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Desmopressin lyophilisate (Melt)
Patients receiving Desmopressin lyophilisate (Melt).
Drug: Desmopressin lyophilisate (Melt)
Patient receives Desmopressin lyophilisate (Melt).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bladder information: voiding calender
Time Frame: Change between day 1 before start of studymedication and 6 months later
Voiding calendar
Change between day 1 before start of studymedication and 6 months later
Urine concentration
Time Frame: Change between day 1 before start of studymedication and 6 months later
Forced diuresis and 24h concentration profile with measurement of Na, K, creatinin, osmolality
Change between day 1 before start of studymedication and 6 months later
IQ (Intelligent Quotient)
Time Frame: Change between day 1 before start of studymedication and 6 months later
Wechsler Intelligence Scale for Children-Third Edition (WISC-III) short version
Change between day 1 before start of studymedication and 6 months later
Psychological functioning questionnaire
Time Frame: Change between day 1 before start of studymedication and 6 months later
Child Behavior Checklist - CBCL (parents)
Change between day 1 before start of studymedication and 6 months later
Psychological functioning questionnaire
Time Frame: Change between day 1 before start of studymedication and 6 months later
"Vragenlijst voor Gedragsproblemen bij Kinderen" (VvGK): questionnaire to screen for ADHD and behavioral disorders (parents, teacher)
Change between day 1 before start of studymedication and 6 months later
Psychological functioning questionnaire
Time Frame: Change between day 1 before start of studymedication and 6 months later
TRF: Teacher Report Form (teacher)
Change between day 1 before start of studymedication and 6 months later
Psychological functioning questionnaire
Time Frame: Change between day 1 before start of studymedication and 6 months later
Behavior Rating Inventory of Executive Function (BRIEF): questionnaire to assess executive functions) (parents, teacher)
Change between day 1 before start of studymedication and 6 months later
Psychological functioning questionnaire
Time Frame: Change between day 1 before start of studymedication and 6 months later
Pediatric Incontinence Questionniare (PinQ): questionnaire to measure health related quality of life, specific enuresis (parents + child)
Change between day 1 before start of studymedication and 6 months later
Psychological functioning questionnaire
Time Frame: Change between day 1 before start of studymedication and 6 months later
Pediatric Quality of Life Inventory (PedsQL): questionnaire to measure health related quality of life (parents + child)
Change between day 1 before start of studymedication and 6 months later
Psychological functioning questionnaire
Time Frame: Change between day 1 before start of studymedication and 6 months later
Kiddie Schedule for Affective Disorders and Schizofrenia (K-SADS): diagnostic interview if CBCL/TRF is (sub)clinical (parents + child)
Change between day 1 before start of studymedication and 6 months later
Psychological functioning questionnaire
Time Frame: Change between day 1 before start of studymedication and 6 months later
Cambridge Neuropsychological Test Automated Battery (CANTAB) (child)
Change between day 1 before start of studymedication and 6 months later
Psychological functioning questionnaire
Time Frame: Change between day 1 before start of studymedication and 6 months later
IQ: WISC-III subtest Digit Span - children are orally given sequences of numbers and asked to repeat them, either as heard or in reverse order. (child)
Change between day 1 before start of studymedication and 6 months later
Psychological functioning questionnaire
Time Frame: Change between day 1 before start of studymedication and 6 months later
Test of Everyday Attention for Children (TEA-ch): subtest Secret code + Score DT (sustained attention task) (child)
Change between day 1 before start of studymedication and 6 months later
Psychological functioning questionnaire
Time Frame: Change between day 1 before start of studymedication and 6 months later
"Competentiebelevingsschaal voor Kinderen/Adolescenten" (CBSK/CBSA): questionnaire to measure self-esteem in children or adolescents OR The pictorial scale of perceived competence and social acceptance for young children. (child)
Change between day 1 before start of studymedication and 6 months later
Psychological functioning questionnaire
Time Frame: Change between day 1 before start of studymedication and 6 months later
Swanson, Kotkin, Agler, Mylnn, and Pelham (SKAMP) Rating Scale: observation scale (teacher)
Change between day 1 before start of studymedication and 6 months later
Psychological functioning questionnaire
Time Frame: Change between day 1 before start of studymedication and 6 months later
School results: copy of schoolreport (+median) (teacher)
Change between day 1 before start of studymedication and 6 months later
Sleep
Time Frame: Change between day 1 before start of studymedication and 6 months later
Pediatric Sleep Questionnaire (questionnaire to assess the quality of sleep) (parents)
Change between day 1 before start of studymedication and 6 months later
Sleep
Time Frame: Change between day 1 before start of studymedication and 6 months later
Children's Sleep Habits Questionnaire (CSHQ) (parents)
Change between day 1 before start of studymedication and 6 months later
Sleep
Time Frame: Change between day 1 before start of studymedication and 6 months later
Polysomnography (overnight hospitalization) (child)
Change between day 1 before start of studymedication and 6 months later

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

Collaborators

Ferring Pharmaceuticals

Investigators

  • Principal Investigator: Johan Vande Walle, MD, PhD, University Hospital, Ghent

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

Helpful Links

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

April 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

July 13, 2012

First Submitted That Met QC Criteria

July 17, 2012

First Posted (Estimate)

July 20, 2012

Study Record Updates

Last Update Posted (Actual)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/247

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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