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

NCT07588659 | Not Yet Recruiting

• 1 other identifier: Sweet BEAD
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity

Keywords

Weighted Blanket; Sleep Disturbances; Sleep; Children; Psychiatry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change From Baseline in Functional Impairment as Assessed by the Weiss Functional Impairment Rating Scale-Parent Form at Week 4

  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

  From enrollment to the end of treatment at 4 weeks

• Change From Baseline in Sleep Efficiency as Assessed by Wrist Actigraphy at Week 4

  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

  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

  From enrollment to the end of treatment at 4 weeks

Other Outcomes (1)

• Change From Baseline in Sensory Processing as Assessed by the Sensory Processing Measure, Second Edition Home Form at Week 4

  From enrollment to the end of treatment at 4 weeks

Study Arms (1)

Retail-grade weighted blanket

EXPERIMENTAL

Sleep with a retail-grade weighted blankets for 28 nights

Device: Sleep Intervention with weighted device

Interventions

Sleep Intervention with weighted device DEVICE

The use of retail-grade weighted blanket among children with ADHD and sleep disturbances aged 5-12 years.

Retail-grade weighted blanket

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Signed informed consent.
• Age 5-12 years.
• Diagnosis of ADHD according to ICD-10 code F90.0, F90.1, F90.9 or F98.8.
• Participated in a usual care sleep hygiene program managed by clinicians 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.

You may not qualify if:

• Have used any type of weighted blanket within a 3-month period.
• 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).
• Another member of the household currently or previously enrolled in the Sweet Dreams Trial or the Sweet BEAD trial.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Parasomnias

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Gustav Due Milling, MSc

CONTACT

+4551197904; gustav.due.milling@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior reseacher

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 15, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 15, 2026

Record last verified: 2026-05