Retail-Grade Weighted Blanket Effectiveness on ADHD-related Sleep Disturbances (BEAD)

Sleep problems are common in children with attention deficit hyperactivity disorder (ADHD) and are associated with worse daytime symptoms, functioning, and family wellbeing. Children with ADHD often experience sensory processing difficulties, including altered responses to touch and movement. These difficulties are linked to problems with falling asleep, staying asleep, and regulating arousal at bedtime.

Weighted blankets are used by some families and clinicians as a non-pharmacological support for sleep problems. The proposed mechanism is deep pressure stimulation, where evenly distributed pressure may reduce arousal through tactile and proprioceptive input. However, evidence for this mechanism and for clinical benefit remains limited.

In Danish child and adolescent mental health care, some children with mental disorders are offered a trial period with a medical-grade weighted blanket. If the family experiences benefit, they can apply for municipal reimbursement of a medical-grade blanket. These blankets are substantially more expensive than retail-grade weighted blankets. Reimbursement applications are often declined because of limited evidence that medical-grade weighted blankets provide benefits beyond lower-cost, commercially available weighted blankets. This reasoning assumes that the main therapeutic component is weight or deep pressure stimulation, and that retail-grade blankets, often filled with glass beads, provide a comparable effect on proprioceptive input and sensory regulation. This assumption lacks clinical evidence. Although weighted blankets have been studied in children with ADHD, existing studies have primarily evaluated prescribed or clinically selected weighted blankets. To our knowledge, no published clinical trial has specifically evaluated lower-cost retail-grade weighted blankets in children with ADHD and sleep disturbances.

The Sweet BEAD trial is designed to examine the use of a commercially available retail-grade weighted blanket in children with ADHD and sleep problems. The study is conducted as a prospective, open-label, single-arm intervention study with assessments before and after the intervention period. All participants receive a retail-grade weighted blanket in addition to their usual care.

The study procedures are aligned with the ongoing Sweet Dreams trial where relevant. Sweet Dreams investigates medical-grade weighted blankets in a randomized controlled trial. Using similar procedures in Sweet BEAD supports later comparison of findings across the two studies, while Sweet BEAD remains an independent evaluation of retail-grade weighted blankets.

Participants complete a baseline period before receiving the blanket. They then use the blanket for four weeks in their home setting. At the intervention visit, the child tries the available blanket options and selects the preferred blanket when possible. If the child is unsure, clinical staff help choose the most suitable option based on comfort, sensory preference, and fit.

Participants and caregivers receive brief guidance from a clinician on how and when to use the blanket. The guidance focuses on practical use in daily routines, including use at night and during short periods of daytime rest. Families also receive a simple explanation of how sensory input may influence arousal and sleep. No formal behavioral sleep program is introduced as part of the study.

The study is designed to reflect real-world use. Families use the blanket at home without strict control of bedtime routines beyond general guidance. Usual care continues as provided by treating clinicians, and the intervention is evaluated as an add-on rather than a replacement for existing treatment. Families are asked not to start or change other sleep-related treatments during the study period if possible.

Sleep is assessed using wrist actigraphy before and during the intervention period. Actigraphy provides an objective estimate of sleep patterns over multiple nights. Caregivers also complete questionnaires on areas relevant to daily life, including child functioning, ADHD symptoms, parental stress, child wellbeing, sensory processing, and health-related quality of life. This combined approach allows assessment of both sleep and daytime impact.

Adherence is monitored throughout the intervention period using simple daily caregiver reports. These reports capture whether the blanket was used during the night, during the day, both, or not at all. A mid-intervention contact with study staff provides an opportunity to ask about blanket use, address practical issues, support continued use, and remind families about the second actigraphy period.

Safety is monitored throughout the intervention period. Caregivers are asked to report any unwanted events, and study staff ask about possible adverse events during follow-up contact. Any reported events are recorded and assessed according to study procedures.

The main analysis will examine whether use of the retail-grade weighted blanket is associated with changes in objectively measured sleep duration from baseline to the end of the intervention period. Additional analyses will examine other sleep measures and caregiver-reported outcomes. The study will also describe adherence, tolerability, and practical barriers to use.

The study will explore whether responses to the intervention differ across subgroups, including age, sex, and sensory processing profile. These analyses are intended to generate hypotheses about which children may benefit most from this type of intervention.

Health-economic data are collected to support a possible within-trial economic evaluation if the intervention shows evidence of benefit. These data could help assess whether a lower-cost retail-grade weighted blanket is a reasonable option from a Danish healthcare perspective.

Long-term follow-up will be conducted for participants who consent to additional follow-up. This will include selected caregiver-reported questionnaires and register-based outcomes after the intervention period. These analyses are exploratory and separate from the main within-trial evaluation.

Findings from this study will help clarify whether retail-grade weighted blankets are associated with improved sleep and related daily outcomes in children with ADHD and sleep disturbances. The results could inform future comparative studies and support decision-making in clinical practice and municipal reimbursement settings.

• Change From Baseline in Functional Impairment as Assessed by the Weiss Functional Impairment Rating Scale-Parent Form at Week 4 [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Change From Baseline in Sleep Onset Latency as Assessed by Wrist Actigraphy at Week 4 [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Change From Baseline in Sleep Efficiency as Assessed by Wrist Actigraphy at Week 4 [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Change From Baseline in Wake After Sleep Onset as Assessed by Wrist Actigraphy at Week 4 [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Change From Baseline in ADHD Core Symptoms as Assessed by the Attention Deficit Hyperactivity Disorder Rating Scale-IV Parent Version at Week 4 [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Change From Baseline in Parental Stress as Assessed by the Parental Stress Scale at Week 4 [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Change From Baseline in Child Wellbeing as Assessed by the World Health Organization-5 Child Well-Being Index at Week 4 [Срок оценки: From enrollment to the end of treatment at 4 weeks]