An interventional study of Sleep Intervention with weighted device in ADHD - Attention Deficit Disorder With Hyperactivity, sponsored by University Hospital Bispebjerg and Frederiksberg. Recruiting at 1 site in Denmark. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by University Hospital Bispebjerg and Frederiksberg · Not applicable, Interventional, and Supportive care
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:
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.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's planned enrollment of 100 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →University Hospital Bispebjerg and Frederiksberg is the lead sponsor of 69 studies on the registry; 18 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sleep with a retail-grade weighted blankets for 28 nights
Device: Sleep Intervention with weighted device
The use of retail-grade weighted blanket among children with ADHD and sleep disturbances aged 5-12 years.
Change From Baseline in Total Sleep Time as Assessed by Wrist Actigraphy at Week 4
Changes in total sleep time (TST) per day extrapolated from baseline to end of treatment, will be measured using actigraphy. 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 MotionWatch 8 (The MotionWatch8®- CamNtech MotionWare). The MotionWatch 8 has been validated among children with autism spectrum disorder. Measurements from at least 5 nights have been recommended to obtain reliable actigraphy measures of sleep for children and adolescents. Children will wear the actigraphy on their non-dominant wrist at baseline one week (week 0) and the last 14 consecutive days of the trial (week 3 and 4). The participants can choose if they want to use the actigraphy at daytime while use at night is mandatory.
Time frame: From enrollment to the end of treatment at 4 weeks
Change From Baseline in Functional Impairment as Assessed by the Weiss Functional Impairment Rating Scale-Parent Form at Week 4
Changes in functional impairment from baseline to end of treatment, measured using Weiss Functional Impairment Rating Scale (WFIRS-P). The WFIRS-P is a 50-item scale assessment tool that can be used to assess functional impairment in 5-19-year-old children. It requires caregivers to rate the impact of their child's emotional or behavioral problems in the previous month on six separate domains: (A) Family (ten items); (B) School and learning; (C) Life skills; (D) Child's self-concept; (E) Social activities; and (F) Risky activities. Each item is rated on a four-point scale from 0 ('never or not at all') to 3 ('very often or very much') or rated as 'not applicable'. The instrument uses a Likert scale with a rating of 2 or 3 being seen as clinically impaired function. The mean of all scored items for each domain will be calculated. Furthermore, a single overall WFIRS-P score will also be calculated as the average of the six domain scores. The scale is highly sensitive to change
Time frame: 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
Changes in sleep onset latency (SOL) from baseline to end of treatment. SOL refers to the period of time between turning lights out to go to sleep and falling asleep. SOL will be measured using actigraphy which includes a button that should be pressed by a caregiver when the lights are turned off. SOL will be reported as minutes per day.
Time frame: From enrollment to the end of treatment at 4 weeks
Change From Baseline in Sleep Efficiency as Assessed by Wrist Actigraphy at Week 4
Changes in sleep efficiency (SE) from baseline to end of treatment. SE is measured using actigraphy and is the actual sleep time expressed as a percentage of the total time in bed (the time elapsed between "lights out" and "get up time"). SE will be reported as a percentage
Time frame: 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
Changes in wake after sleep onset (WASO) from baseline to end of treatment. Wake after sleep is defined as number of minutes scored as wake during sleep period and will be measured using actigraphy
Time frame: 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
The Attention Deficit Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) yields a total score ranging from 0 to 78, with three subscores: inattentive (0-27), hyperactive/impulsive (0-27), and conduct problems (0-24). Higher scores indicate greater severity of ADHD symptoms and impairments. Changes from baseline to end of treatment in ADHD core symptoms (caregiver rated) measured with Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) parent version. The ADHD-RS instrument is developed to determine the frequency and severity of ADHD symptoms and impairments among children aged 5-17 years during the last six months if no other agreement has been made. In our study, parents will be asked to assess ADHD core symptoms during the last month. It has been validated among 6-16-year-old Danish children.
Time frame: 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
The Parental Stress Scale yields a total score ranging from 18 to 90. Higher scores indicate greater levels of parental stress. Changes in mean average score from baseline to end of treatment in parental stress life measured by the Parental Stress Scale (PSS). The PSS is an 18-item questionnaire assessing parents' feelings about their parenting role, exploring both positive aspects (e.g., emotional benefits, personal development) and negative aspects of parenthood (e.g., demands on resources, feelings of stress). Parents can agree or disagree in terms of their typical relationship with their child or children.
Time frame: 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
The World Health Organisation Child Well-Being Index (WHO-5 Child Wellbeing Index) yields a total score ranging from 0 to 100, calculated by summing the five item scores and multiplying by 5. Higher scores indicate better psychological wellbeing. Changes in child quality of life score from baseline to end of treatment will be measured using the WHO-5. The WHO-5 Child Wellbeing Index is a simple self-reported measure of children's psychological wellbeing. It consists of five, positively phrased questions, which can be administered in under five minutes. It was introduced in its current form in 1998 by WHO Regional Office in Europe for use with children aged nine and above.
Time frame: From enrollment to the end of treatment at 4 weeks
Change From Baseline in Sensory Processing as Assessed by the Sensory Processing Measure, Second Edition Home Form at Week 4
Changes from baseline to end of trial in Sensory Processing Measure 2 (SPM-2). The Sensory Processing Measure, Second Edition forms are designed to five age levels: Infant/toddler, preschool, child, adolescent and adults. The SPM-2 Home form (caregiver form) is normed for children aged 5 to 12 years and provides a complete picture of children's sensory processing difficulties at home during the last month. The SPM home form consists of 80 Likert-type items completed by a caregiver and takes approximately 20 to 30 minutes to complete. A total score below 60 is defined 'normal, a total score of 60-69 is defined 'Some problems', and a total score above 70 is defined as 'definite dysfunction'.
Time frame: From enrollment to the end of treatment at 4 weeks
Plan to share: Undecided
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Started Aug 2026 (actual). Primary completion is estimated for Apr 2027, 8 months after the start.
Of 479 non-industry interventional studies with no phase under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 8 months is below that.
Counting every sponsor, half of 510 studies reached it within 23 months; a quarter within 11 and three quarters within 41.
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Attention Deficit Disorder with Hyperactivity →
University Hospital Bispebjerg and Frederiksberg