Retail-Grade Weighted Blanket Effectiveness on ADHD-related Sleep Disturbances (BEAD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorUniversity Hospital Bispebjerg and Frederiksberg
About this 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 child well-being? * Do 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. * 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Sleep Intervention with weighted device
DeviceThe use of retail-grade weighted blanket among children with ADHD and sleep disturbances aged 5-12 years.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Retail-grade weighted blanketExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
From enrollment to the end of treatment at 4 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksOther outcomes
1
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 weeksSponsors and contacts
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Source ClinicalTrials.gov