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

July 13, 2012
July 17, 2012
April 2011
August 2012   (final data collection date for primary outcome measure)
  • 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)
Same as current
Complete list of historical versions of study NCT01645475 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Desmopressin Melt: Impact on Sleep and Daytime Functioning
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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Monosymptomatic Nocturnal Enuresis.
Drug: Desmopressin lyophilisate (Melt)
Patient receives Desmopressin lyophilisate (Melt).
Experimental: Desmopressin lyophilisate (Melt)
Patients receiving Desmopressin lyophilisate (Melt).
Intervention: Drug: Desmopressin lyophilisate (Melt)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
6 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01645475
2010/247
No
University Hospital, Ghent
University Hospital, Ghent
Ferring Pharmaceuticals
Principal Investigator: Johan Vande Walle, MD, PhD Ghent University Hospital
University Hospital, Ghent
July 2012

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