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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Ferring Pharmaceuticals

Information provided by (Responsible Party):

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT01645475

First received: July 13, 2012

Last updated: July 17, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 13, 2012

Last Updated Date

July 17, 2012

Start Date ^ICMJE

April 2011

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bladder information: voiding calender [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
Voiding calendar
Urine concentration [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
Forced diuresis and 24h concentration profile with measurement of Na, K, creatinin, osmolality
IQ (Intelligent Quotient) [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
Wechsler Intelligence Scale for Children-Third Edition (WISC-III) short version
Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
Child Behavior Checklist - CBCL (parents)
Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
"Vragenlijst voor Gedragsproblemen bij Kinderen" (VvGK): questionnaire to screen for ADHD and behavioral disorders (parents, teacher)
Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
TRF: Teacher Report Form (teacher)
Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
Behavior Rating Inventory of Executive Function (BRIEF): questionnaire to assess executive functions) (parents, teacher)
Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
Pediatric Incontinence Questionniare (PinQ): questionnaire to measure health related quality of life, specific enuresis (parents + child)
Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
Pediatric Quality of Life Inventory (PedsQL): questionnaire to measure health related quality of life (parents + child)
Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
Kiddie Schedule for Affective Disorders and Schizofrenia (K-SADS): diagnostic interview if CBCL/TRF is (sub)clinical (parents + child)
Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
Cambridge Neuropsychological Test Automated Battery (CANTAB) (child)
Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
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)
Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
Test of Everyday Attention for Children (TEA-ch): subtest Secret code + Score DT (sustained attention task) (child)
Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
"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)
Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
Swanson, Kotkin, Agler, Mylnn, and Pelham (SKAMP) Rating Scale: observation scale (teacher)
Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
School results: copy of schoolreport (+median) (teacher)
Sleep [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
Pediatric Sleep Questionnaire (questionnaire to assess the quality of sleep) (parents)
Sleep [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
Children's Sleep Habits Questionnaire (CSHQ) (parents)
Sleep [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
Polysomnography (overnight hospitalization) (child)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01645475 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Desmopressin Melt: Impact on Sleep and Daytime Functioning

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Monosymptomatic Nocturnal Enuresis.

Intervention ^ICMJE

Drug: Desmopressin lyophilisate (Melt)

Patient receives Desmopressin lyophilisate (Melt).

Study Arm (s)

Experimental: Desmopressin lyophilisate (Melt)

Patients receiving Desmopressin lyophilisate (Melt).

Intervention: Drug: Desmopressin lyophilisate (Melt)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

August 2012

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01645475

Other Study ID Numbers ^ICMJE

2010/247

Has Data Monitoring Committee

Responsible Party

University Hospital, Ghent

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Ferring Pharmaceuticals

Investigators ^ICMJE

Principal Investigator:

Johan Vande Walle, MD, PhD

Ghent University Hospital

Information Provided By

University Hospital, Ghent

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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