Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06194162
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-11-21
Brief Title:
Weighted Blankets for Sleep Disturbance Among Children With ADHD
Sponsor:
University Hospital Bispebjerg and Frederiksberg
Organization:
University Hospital Bispebjerg and Frederiksberg
Study Overview
Official Title:
Impact of Weighted Blankets on Sleep Disturbance Among Children With Attention Deficit Hyperactivity Disorders A Pragmatic Randomised Trial
Status:
RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
Many children with ADHD suffer from sleep disorders and dysfunction which may affect development and well-being According to the clinicians some children find relief from restlessness and difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory integration and to calm the child by stimulating the sense of touch muscles and joints However evidence for an effect on sleep is scarce and only one RCT has investigated the effect of weighted blankets among children with ADHD Using a RCT design the aim is to investigate the effect on sleep disorders and dysfunction in children with ADHD aged 5-12 years by 1 using a weighted blanket during night and daytime in addition to usual treatment compared to 2 usual treatment and a non-weighted sham blanket with the primary outcome being differences in total sleep time Results will support health- and social professionals who are involved in the treatment of children with ADHD
Detailed Description:
Over the past decade interest in the relationship between sleep difficulties and ADHD has increased with evidence showing that sleep problems are very common among school children with ADHD affecting nearly three-quarters Sleep problems may worsening daytime behaviors and may also affect the overall wellbeing of the family leading to poorer parental mental health and higher stress According to the clinicians some children find relief from restlessness and difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory integration and to calm the child by stimulating the sense of touch muscles and joints However evidence for an effect on sleep is scarce and only one RCT has investigated the effect of weighted blankets among children with ADHD Using a RCT design the aim is to investigate the effect on sleep disorders and dysfunction in children with ADHD aged 5-12 years by 1 using a weighted blanket during night and daytime in addition to usual treatment compared to 2 usual treatment and a non-weighted sham blanket with the primary outcome being differences in total sleep time
The study is designed as a superiority trial a parallel group randomised controlled trial where participants are randomised to one of two study arms 11 The sample consists of 340 participants divided into two groups After randomisation each participant will stay in their assigned treatment arm during the entire study For each study participant the active intervention period is 28 days with assessment of primary and secondary outcomes at baseline and after 28 days of intervention Thereafter participants will be followed through national health registers
The trial will take place at the Child and Adolescent Mental Health Center Mental Health Services in the Capital Region of Denmark This center is providing assessment and treatment of children and adolescents with psychiatric disorders
The study is designed as a superiority trial a parallel group randomised controlled trial where participants are randomised to one of two study arms 11 The sample consists of 340 participants divided into two groups After randomisation each participant will stay in their assigned treatment arm during the entire study For each study participant the active intervention period is 28 days with assessment of primary and secondary outcomes at baseline and after 28 days of intervention Thereafter participants will be followed through national health registers
The trial will take place at the Child and Adolescent Mental Health Center Mental Health Services in the Capital Region of Denmark This center is providing assessment and treatment of children and adolescents with psychiatric disorders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None