Retail-Grade Weighted Blanket Effectiveness on ADHD-related Sleep Disturbances - The Sweet BEAD Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change From Baseline in Total Sleep Time as Assessed by Wrist Actigraphy at Week 4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Age 5-12 years.
- •Diagnosis of ADHD according to ICD-10 code F90.0, F90.1, F90.9 or F98.
- •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.
排除标准
- •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.
研究组 & 干预措施
Retail-grade weighted blanket
Sleep with a retail-grade weighted blankets for 28 nights
干预措施: Sleep Intervention with weighted device (Device)
结局指标
主要结局
Change From Baseline in Total Sleep Time as Assessed by Wrist Actigraphy at Week 4
时间窗: From enrollment to the end of treatment at 4 weeks
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.
次要结局
- 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)
- Change From Baseline in Parental Stress as Assessed by the Parental Stress Scale at Week 4(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(From enrollment to the end of treatment at 4 weeks)
研究者
Ina Olmer Specht
Principal Investigator
University Hospital Bispebjerg and Frederiksberg