Ignite Creation Date:
2024-05-06 @ 12:43 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01645475
Status:
COMPLETED
Last Update Posted:
2022-12-15
First Post:
2012-07-13
Brief Title:
Desmopressin Melt Impact on Sleep and Daytime Functioning
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Desmopressin Melt Impact on Sleep and Daytime Functioning A Prospective Study
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLEEP
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 bladderUrine 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 Alevel 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
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 Alevel 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None