Weighted Blankets for Sleep Disturbance Among Children With ADHD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorUniversity Hospital Bispebjerg and Frederiksberg

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Have used any type of medical device class 1 weighted blanket before.

Any diagnosed diseases that markedly compromises the participant's ability to adhere to the intervention (like mental retardation, severe underweight, chronic respiratory or circulatory conditions, surgical implants, osteoporosis).

Another member of the household enrolled in the trial.

Trial design

Treatments tested in this trial

  • Weighted blanket
  • Non-weighted blanket

Treatment groups

340 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital Bispebjerg and Frederiksberg

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Collaborator