Impact of Weighted Blankets on Sleep Disturbance Among Children With Attention Deficit Hyperactivity Disorders: A Pragmatic Randomised Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 12
Healthy Volunteers: f
View:

• Signed informed consent.

• Age 5-12 years (both included) at randomization.

• Primary diagnosis of ADHD according to ICD-10 code F90.0, F90.1, F90.9 or F98.8.

• Comorbidities are allowed.

• Participated in a usual care sleep hygiene program managed by clinicians without effect within 6 months prior to enrollment.

• If on ADHD medication or/and melatonin/sleep medication the dose must be stable, at least two weeks prior to enrollment.

• The child and caregiver have adequate mastery of the Danish language.

Locations
Other Locations
Denmark
The Parker Institute, Bispebjerg and Frederiksberg Hospital
RECRUITING
Frederiksberg
Contact Information
Primary
Ina O. Specht, Ph.d.
ina.olmer.specht@regionh.dk
+45 51197904
Backup
Jeanett F. Rohde, Ph.d.
jeanett.friis.rohde@regionh.dk
+45 51197904
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2028-08-01
Participants
Target number of participants: 340
Treatments
Experimental: Weighted blanket
The intervention group will receive a weighted blanket classified as a medical device class 1 as an add on to usual treatment.
Sham_comparator: Non-weighted blanket
The control comparator group will receive a sham intervention in the form of a non-weighted blanket. as an add on to usual treatment.
Sponsors
Leads: University Hospital Bispebjerg and Frederiksberg
Collaborators: Mental Health Services in the Capital Region, Denmark

This content was sourced from clinicaltrials.gov