Retail-Grade Weighted Blanket Effectiveness on ADHD-related Sleep Disturbances - The Sweet BEAD Trial
Retail-Grade Weighted Blanket Effectiveness on ADHD-related Sleep Disturbances - The Sweet BEAD Trial
The goal of this clinical trial is to investigate if a commercially available (retail-grade) weighted blanket can improve sleep in children with Attention Deficit Hyperactivity Disorder (ADHD) and sleep disturbances. 100 children will be enrolled in the study. The location of the intervention is at Frederiksberg Hospital and Odense University Hospital in Denmark. The main objectives are:
This is a single-group, open-label study. All participants receive a weighted blanket, and researchers compare each child's sleep before and after the 4-week blanket intervention period.
Who can take part:
Children aged 5 to 12 years who have a confirmed ADHD diagnosis, and also experience sleep disturbances. Children must have completed a usual-care sleep hygiene program within the last 6 months. if they use ADHD medicine or sleep medication the dosage must be stable for at least two weeks before enrolling. Children who used any type of weighted blanket within the last three months, or have health conditions that make blanket use unsafe, cannot take part in the trial.
What will happen:
Participation lasts about seven weeks, including measurements before and during the weighted blanket intervention period.
Participants will:
Attend a baseline visit (in person or online) where a caregiver gives consent and receives instructions.
Wear a small sleep monitor (actigraphy) on the non-dominant wrist for 1 week before starting the blanket
Attend an intervention visit to try the weighted blanket options and choose the most fitting weighted blanket for their sensory needs.
Use the weighted blanket every night for four weeks. During the day, the child will also use the blanket for about 10 minutes while sitting and relaxing.
Wear the sleep monitor again during the last two weeks of the 4-week blanket intervention period.
Receive a short follow-up phone call about two weeks after starting the blanket intervention period to ask about blanket use and reminding the initiation of the second actigraphy period.
A caregiver will receive a daily text message to report whether the blanket was used (day and/or night).
Complete questionnaires that are sent to them at the end of trial. A final end of trial phone call is completed where the caregiver will be asked if the child has had other treatments or change in their medication usage in the trial period.
2 years follow-up: Researchers may contact families again two years after the blanket intervention period to repeat key questionnaires. Researchers will also look at selected long-term outcomes in health and education registers at two and five years after the end of the intervention period, if agreed upon.
Outcome Measures:
The primary outcome is the change in TST measured by actigraphy from baseline to the end of the 4-week intervention period. Secondary outcomes include other actigraphy sleep measures (time to fall asleep, number of awakenings, wake time after falling asleep, and sleep efficiency) and questionnaire scores on functioning, ADHD symptoms, parental stress, sensory processing, and child well-being/quality of life. Researchers will also record adverse events and serious adverse events during the enrollment period.
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.
Inclusion Criteria:
Exclusion Criteria:
gustav.due.milling@regionh.dk+4551197904