Impact of Weighted Blankets on Sleep Disturbance Among Children With Attention Deficit Hyperactivity Disorders: A Pragmatic Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 340
- 试验地点
- 2
- 主要终点
- Changes in total sleep time (average minutes per day)
研究概览
简要总结
Many children with ADHD suffer from sleep disorders and dysfunction, which may affect development and well-being. According to the clinicians, some children find relief from restlessness and difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory integration and to calm the child by stimulating the sense of touch, muscles and joints. However, evidence for an effect on sleep is scarce, and only one RCT has investigated the effect of weighted blankets among children with ADHD. Using a RCT design, the aim is to investigate the effect on sleep disorders and dysfunction in children with ADHD aged 5-12 years by (1) using a weighted blanket during night and daytime in addition to usual treatment, compared to (2) usual treatment and a non-weighted sham blanket, with the primary outcome being differences in total sleep time. Results will support health- and social professionals who are involved in the treatment of children with ADHD.
详细描述
Over the past decade, interest in the relationship between sleep difficulties and ADHD has increased, with evidence showing that sleep problems are very common among school children with ADHD, affecting nearly three-quarters. Sleep problems may worsening daytime behaviors and may also affect the overall wellbeing of the family, leading to poorer parental mental health and higher stress. According to the clinicians, some children find relief from restlessness and difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory integration and to calm the child by stimulating the sense of touch, muscles and joints. However, evidence for an effect on sleep is scarce, and only one RCT has investigated the effect of weighted blankets among children with ADHD. Using a RCT design, the aim is to investigate the effect on sleep disorders and dysfunction in children with ADHD aged 5-12 years by (1) using a weighted blanket during night and daytime in addition to usual treatment, compared to (2) usual treatment and a non-weighted sham blanket, with the primary outcome being differences in total sleep time.
The study is designed as a superiority trial: a parallel group, randomised controlled trial, where participants are randomised to one of two study arms 1:1. The sample consists of 340 participants, divided into two groups. After randomisation each participant will stay in their assigned treatment arm during the entire study. For each study participant, the active intervention period is 28 days with assessment of primary and secondary outcomes at baseline and after 28 days of intervention. Thereafter participants will be followed through national health registers.
The trial will take place at the Child and Adolescent Mental Health Center, Mental Health Services in the Capital Region of Denmark. This center is providing assessment and treatment of children and adolescents with psychiatric disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to treatment allocation where possible. Researchers will be blinded through data management and analysis. By introducing a sham blanket, participants and parents will not be made aware of their assigned intervention during the trial.
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 (both included) at randomization.
- •Primary diagnosis of ADHD according to ICD-10 code F90.0, F90.1, F90.9 or F98.
- •Comorbidities are allowed.
- •Participated in a usual care sleep hygiene program managed by clinicians without effect 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 medical device class 1 weighted blanket before.
- •Any diagnosed diseases that markedly compromises the participant's ability to adhere to the intervention (like mental retardation, severe underweight, chronic respiratory or circulatory conditions, surgical implants, osteoporosis).
- •Another member of the household enrolled in the trial.
研究组 & 干预措施
Weighted blanket
The intervention group will receive a weighted blanket classified as a medical device class 1 as an add on to usual treatment.
干预措施: Weighted blanket (Device)
Non-weighted blanket
The control comparator group will receive a sham intervention in the form of a non-weighted blanket. as an add on to usual treatment.
干预措施: Non-weighted blanket (Device)
结局指标
主要结局
Changes in total sleep time (average minutes per day)
时间窗: Week 0 and 4
Total sleep time (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 MotionWare 8 (The MotionWare 8®-CamNtech MotionWare).
次要结局
- Adverse events (Number of participants with adverse events)(During intervention)
- Changes in sleep efficiency (percentage)(Week 0 and 4)
- Changes in ADHD core symptoms (score point)(Week 0 and 4)
- Changes in functional impairment(Week 0 and 4)
- Changes in sleep onset latency (average minutes per day)(Week 0 and 4)
- Changes in number of awakenings (numbers per night)(Week 0 and 4)
- Changes in child quality of life (score point)(Week 0 and 4)
- Changes in parental stress (score point)(Week 0 and 4)
- Serious adverse events (Number of participants with serious adverse events)(During intervention)
研究者
Ina Olmer Specht
Senior reseacher
University Hospital Bispebjerg and Frederiksberg