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

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:

• Does using a retail-grade weighted blanket increase total sleep time (TST)?
• Does it help children fall asleep faster, wake up fewer times at night, and sleep more efficiently overall?
• Does better sleep relate to changes in daily functioning, ADHD symptoms, parental stress, and chill well-being?
• Does adverse events occur while children use retail-grade weighted blankets?

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.
• Receiving 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.

Study Overview

• Status: Not yet recruiting
• Conditions: ADHD - Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Device: Sleep Intervention with weighted device

Detailed Description

BACKGROUND AND RATIONALE Sleep disturbances affect up to 70% of children with Attention Deficit Hyperactivity Disorder (ADHD), exacerbating core ADHD symptoms and negatively affecting family quality of life. Sleep problems in children with ADHD include difficulties initiating sleep and maintaining sleep, as well as increased tiredness on waking and daytime sleepiness. Given the likely bidirectional relationship between sleep disturbance and daytime ADHD symptoms, improving sleep is considered an important component of overall ADHD management.

Children with ADHD also show higher rates of sensory processing difficulties compared to typically developing children, including atypical touch and movement processing. Sleep difficulties in this population have specifically been associated with sensory modulation difficulties, suggesting that interventions targeting sensory processing, such as deep pressure stimulation may be particularly relevant.

Weighted blankets are increasingly used by families and professionals as a non-pharmacological intervention for sleep disturbances in children with ADHD. The hypothesized mechanism involves deep pressure stimulation (DPS) modulating physiological arousal through proprioceptive input. Evidence for this mechanism and for clinical effectiveness remains limited. Current evidence suggests that weighted blankets may have beneficial effects on sleep and daily functioning in children with ADHD and related neurodevelopmental conditions. However, the evidence base remains limited, and findings are not yet sufficient to determine whether retail-grade weighted blankets provide clinically meaningful benefits in this population.

In Danish clinical practice, children with mental health disorders may be offered a trial of medical-grade weighted blankets (approximately DKK 7,000), with the option of applying to their municipality for reimbursement. Danish municipalities have increasingly declined reimbursement applications, citing insufficient evidence to differentiate medical-grade blankets from lower-cost, commercially available (retail-grade) blankets typically filled with glass beads. No clinical trial data currently exist on the effectiveness of retail-grade weighted blankets in children with ADHD and sleep disturbances. The Sweet BEAD trial is designed to address this evidence gap directly.

This trial is designed as a companion to the ongoing Sweet Dreams randomized controlled trial, which investigates medical-grade weighted blankets versus a light fiber control blanket. The Sweet BEAD trial mirrors the Sweet Dreams study procedures where applicable, to allow for potential future comparisons between retail-grade and medical-grade blankets.

STUDY DESIGN

This is a prospective, open-label, single-arm interventional study with pre-post assessments. All enrolled participants receive a retail-grade weighted blanket as an add-on to their usual treatment for 28 consecutive days and nights. The study uses the same data collection infrastructure, outcome instruments, and standard operating procedures as the Sweet Dreams trial, with the exception of all procedures related to randomization, allocation concealment and blinding.

The total duration of study participation per participant is approximately 7 weeks: one week of baseline actigraphy measurement (Week 0), the 4-week blanket intervention period (Weeks 1-4), and approximately one additional week for return of equipment and completion of end-of-trial questionnaires.

INTERVENTION

Participants will receive one of two available retail-grade weighted blankets, differing in weight class. Selection is made at the intervention visit after the participant has had the opportunity to try both blankets. Where the participant is uncertain, the most suitable blanket is chosen by the assisting physiotherapist or clinical research staff based on clinical judgment.

The weighted blankets included in the trial are produced by a commercial supplier. Participants are guided to use the blanket every night for 28 nights and during the daytime for approximately 10 minutes while sitting and relaxing, for example in a sofa or chair after school. A clinician provides the participant and caregiver with theoretical background on sensory integration and the potential mechanism of weighted blankets. Participants are asked not to use any other type of weighted blanket during the trial period and to avoid initiating or changing other treatments.

OUTCOME ASSESSMENT

The primary outcome is change in total sleep time (TST), measured in average minutes per night by wrist actigraphy (MotionWatch 8). Baseline actigraphy is worn for 7 consecutive days; end-of-trial actigraphy covers the final 14 consecutive days of the intervention period (Weeks 3-4). A minimum of 5 valid nights is required for reliable estimates.

Secondary actigraphy outcomes are sleep onset latency (SOL), sleep efficiency (SE), and wake after sleep onset (WASO), all measured at baseline and end of trial. Secondary questionnaire outcomes assessed at baseline and end of trial are: functional impairment (WFIRS-P), ADHD core symptoms (ADHD-RS-IV), parental stress (PSS), and child wellbeing (WHO-5 Child).

The explorative outcome is sensory processing (SPM-2), assessed at baseline and end of trial.

Health Economics Outcomes:

Health-related quality of life is assessed for children using the EuroQol 5-Dimension Youth version (EQ-5D-3L-Y; caregiver-proxy report) and for caregivers using EQ-5D-3L. Both instruments cover five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) at three levels. The EQ-5D-3L-Y includes a Visual Analogue Scale (0-100) for overall child health. Caregiver productivity loss is assessed using the Work Productivity and Activity Impairment questionnaire - General Health (WPAI-GH), supplemented with three additional items replacing "your health problems" with "your child's health problems" to capture child-attributable productivity loss specifically. These outcomes are used solely for within-trial cost-effectiveness analysis and are not primary or secondary efficacy endpoints.

Long-Term Follow-Up:

Two years after the end of the intervention period, participants who consented to follow-up will be contacted by secure digital mail and asked to complete the end-of-trial questionnaire battery again. Register-based follow-up is planned at two and five years after end of trial, using Danish national registers including the National Test Program, the Student Register (grades), the Danish Health Insurance Register (referrals to health specialists), and Statistics Denmark (upper secondary education for participants aged 10-12 at end of trial).

PARTICIPANT SAFETY AND ADVERSE EVENTS No known risks, side effects, or disadvantages are associated with weighted blanket use. Unforeseen adverse events (AEs) are monitored continuously throughout the trial. An AE is defined as any untoward occurrence in a study participant, regardless of causal relationship to the intervention, including any worsening of a pre-existing condition.

AEs are collected from the time of blanket acquisition through 28 days of use. At the mid-trial call (approximately day 14), project personnel ask the caregiver about blanket use, possible AEs, and any changes in concurrent treatment. Caregivers are also asked to contact project personnel if an AE occurs at any time.

A serious adverse event (SAE) is defined as any event resulting in death, being life-threatening, requiring hospitalization or prolongation of hospitalization, resulting in persistent disability or incapacity, or constituting a medically important event. SAEs are to be reported to the Sponsor within 24 hours. The investigator will contact the blanket manufacturer and, in the case of SAEs related to blanket use, the Danish Medicines Agency. If an SAE is judged to be a suspected unexpected serious adverse reaction (SUSAR), it must be reported to the national competent authority within 7 days (life-threatening) or 15 days (non-life-threatening).

The relationship of each AE to the study intervention is classified by the investigator as: Probably Related, Probably Not Related, or Not Related, with an alternative aetiology required for the latter two classifications.

SAMPLE SIZE AND STATISTICAL ANALYSIS

Sample Size:

The study will enroll 100 participants. Based on a standard deviation of 46 minutes for total sleep time (derived from a prior RCT among children with ADHD), 100 participants will provide 85% statistical power to detect a mean within-subject change of 15 minutes in TST. A change of 15 minutes has been identified as a small but clinically relevant change in total sleep time among children with ADHD. Participants who withdraw will not be replaced.

Study Population:

The as-observed (AO) population consists of all participants who have the outcome of interest assessed at the relevant time point; no imputation of missing data is performed. The per-protocol (PP) population is the subset of the AO population that meets all of the following criteria: a valid baseline actigraphy measurement, a valid end-of-trial actigraphy measurement, no major protocol violations, and reported blanket use on at least 60% of intervention days (assessed via daily caregiver text message).

Statistical Analysis:

A detailed statistical analysis plan will be finalized before the last participant completes the study. For the primary outcome (TST), a paired-sample t-test will be applied if data are normally distributed; otherwise a Wilcoxon signed-rank test will be used. Changes from baseline in continuous secondary outcomes will be analyzed using appropriate within-participant statistical methods. For normally distributed variables, paired tests or linear models adjusting for baseline values will be used; for non-normally distributed variables, non-parametric alternatives will be applied. All statistical tests are two-sided with a significance threshold of p ≤ 0.05. Ninety-five percent confidence intervals will be reported for all estimated mean changes.

Missing data will be handled using methods appropriate to the pattern and mechanism of missingness, as specified in the statistical analysis plan.

Subgroup Analyses:

Pre-specified subgroup analyses will examine potential interactions with sex (girl/boy/other), age group (5-9 years vs. 10-12 years), and sensory processing profile (atypical vs. typical, based on SPM-2 T-score). These analyses will be conducted by including interaction terms in the appropriate statistical models.

Economic Analysis:

If the intervention is found to be effective on the primary outcome, a within-trial cost-effectiveness analysis and cost-utility analysis will be conducted from the Danish healthcare system perspective. Costs will be expressed in Danish Kroner (DKK) and health outcomes in quality-adjusted life years (QALYs) calculated from EQ-5D-Y and EQ-5D-3L scores. Costs will include trial administration and coordination, staff time, equipment, intervention materials, and health service utilization. Indirect costs will be restricted to caregiver productivity loss (assessed via WPAI-GH and child-specific supplementary items).

DATA MANAGEMENT AND QUALITY

All study data are collected and stored in REDCap (Research Electronic Data Capture), a secure, web-based data management platform meeting regulatory standards for clinical trial data management and data protection. Baseline questionnaires are completed electronically by caregivers via a secure link sent through digital secure mail. Daily adherence data are collected via automated text message links. Source data include electronic patient records (for diagnosis, medication, and comorbidities), actigraphy device outputs, and eCRFs completed by participants and clinical staff.

Data quality is maintained through REDCap's built-in validation functions, including field-level range checks and mandatory field completion. The study will be conducted in accordance with Danish law, the Helsinki Declaration, the General Data Protection Regulation, and ICH Good Clinical Practice standards. The Danish Data Protection Agency has been notified. Participant data are pseudonymized; data linking participant identity to study data is stored separately and securely.

Monitoring and auditing access will be provided to the Sponsor, regulatory authorities, and ethics committees as required. All paper and electronic records are retained in accordance with Parker Institute standard procedures.

RECRUITMENT AND ENROLLMENT

Recruitment will take place through multiple channels: referrals from public and private child and adolescent psychiatric clinics, social media, and patient organizations. At public and private clinics, clinical staff briefly inform eligible families and, with consent, forward contact details to the project team via Sundhedsplatformen. Families may also self-refer via a project homepage or QR code posters displayed at clinics.

Initial eligibility screening is conducted via telephone by project personnel, who also provide oral study information to the caregiver. Eligible families receive written information materials via secure digital mail and are scheduled for a baseline visit.

The baseline visit takes place at Frederiksberg Hospital or, if necessary, via video call. Informed consent is obtained from the caregiver (and from the child where developmentally appropriate) at or following this visit. The caregiver is given a minimum of 24 hours to consider participation before signing the consent form. The intervention visit is held at The Parker Institute (Frederiksberg Hospital) or Odense University Hospital, preferably 8-14 days after the baseline visit to allow for 7 days of baseline actigraphy collection.

PATIENT AND PUBLIC INVOLVEMENT

The design of the Sweet BEAD trial builds on patient and public involvement and engagement (PPIE) conducted for the Sweet Dreams trial. Two patient research partners (PRPs) - one with a child diagnosed with ADHD only and one with a child diagnosed with both ADHD and autism spectrum disorder - participated in the co-design of the study protocol, contributed to discussions of design relevance and feasibility, completed the trial questionnaires in REDCap as a burden assessment, and reviewed the written participant information. Patient organizations will be engaged during dissemination of results.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gustav Due Milling, MSc; Phone Number: +4551197904; Email: gustav.due.milling@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed informed consent.
2. Age 5-12 years.
3. Diagnosis of ADHD according to ICD-10 code F90.0, F90.1, F90.9 or F98.8.
4. Participated in a usual care sleep hygiene program managed by clinicians within 6 months prior to enrollment.
5. If on ADHD medication or/and melatonin/sleep medication the dose must be stable, at least two weeks prior to enrollment.
6. The child and caregiver have adequate mastery of the Danish language.

Exclusion Criteria:

1. Have used any type of weighted blanket within a 3-month period.
2. Any diagnosed diseases that markedly compromises the participant's ability to adhere to the intervention (like severe or deep mental retardation, severe underweight, chronic respiratory or circulatory conditions, surgical implants, osteoporosis).
3. Another member of the household currently or previously enrolled in the Sweet Dreams Trial or the Sweet BEAD trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Retail-grade weighted blanket; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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	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.	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.	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 World Health Organisation - Child Well-Being Index (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.	From enrollment to the end of treatment at 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Children; Sleep; Psychiatry; Sleep Disturbances; Weighted Blanket
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Parasomnias; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: Sweet BEAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No