Impact of Weighted Blankets on Sleep Disturbance Among Children With Attention Deficit Hyperactivity Disorders: A Pragmatic Randomised Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Attention-deficit Hyperactivity
- Sponsor
- University Hospital Bispebjerg and Frederiksberg
- Enrollment
- 340
- Locations
- 1
- Primary Endpoint
- Changes in total sleep time (average minutes per day)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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 1:1. 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.
Investigators
Ina Olmer Specht
Senior reseacher
University Hospital Bispebjerg and Frederiksberg
Eligibility Criteria
Inclusion Criteria
- •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.
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Changes in total sleep time (average minutes per day)
Time Frame: Week 0 and 4
Total sleep time (TST) is defined as the time of total sleep episode minus the awake time (the entire time spent sleeping) and reported in minutes per day. TST per day will be measured using actigraphy in form of MotionWare 8 (The MotionWare 8®-CamNtech MotionWare).
Secondary Outcomes
- Adverse events (Number of participants with adverse events)(During intervention)
- Changes in sleep efficiency (percentage)(Week 0 and 4)
- Changes in ADHD core symptoms (score point)(Week 0 and 4)
- Changes in functional impairment(Week 0 and 4)
- Changes in sleep onset latency (average minutes per day)(Week 0 and 4)
- Changes in number of awakenings (numbers per night)(Week 0 and 4)
- Changes in child quality of life (score point)(Week 0 and 4)
- Changes in parental stress (score point)(Week 0 and 4)
- Serious adverse events (Number of participants with serious adverse events)(During intervention)