Clinical trial NCT06194162: Weighted Blankets for Sleep Disturbance Among Children With ADHD
Official title: Impact of Weighted Blankets on Sleep Disturbance Among Children With Attention Deficit Hyperactivity Disorders: A Pragmatic Randomised Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention-deficit Hyperactivity
Attention Deficit Hyperactivity Disorder
Neurodevelopmental Disorders
Sleep Disturbance
Attention Deficit Disorder
Hyperkinetic Conduct Disorder
Attention-Deficit Hyperactivity Disorder, Unspecified Type
Keywords: ADHD
weighted blanket
Children
Randomised controlled trial
Sleep Disturbance
ADD
Functional impairment
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: Mental Health Services in the Capital Region, Denmark
First posted: 2024-01-08
Enrollment: 340
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed as a randomised controlled trial with two parallel groups.

Participants will be randomly assigned 1:1 into two groups using computer-generated random numbers. The allocation sequence will be stratified by age (5-8 years vs 9-12 years), ADHD medication (yes vs no) and use of melatonin/sleep medication (yes vs no).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent.
2. Age 5-12 years (both included) at randomization.
3. Primary diagnosis of ADHD according to ICD-10 code F90.0, F90.1, F90.9 or F98.8.
4. Comorbidities are allowed.
5. Participated in a usual care sleep hygiene program managed by clinicians without effect within 6 months prior to enrollment.
6. If on ADHD medication or/and melatonin/sleep medication the dose must be stable, at least two weeks prior to enrollment.
7. The child and caregiver have adequate mastery of the Danish language.

Exclusion Criteria:

1. Have used any type of medical device class 1 weighted blanket before.
2. 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).
3. Another member of the household enrolled in the trial.

Primary outcomes:
measure: Changes in total sleep time (average minutes per day)
timeFrame: Week 0 and 4
Secondary outcomes:
measure: Changes in functional impairment
timeFrame: Week 0 and 4
measure: Changes in sleep onset latency (average minutes per day)
timeFrame: Week 0 and 4
measure: Changes in number of awakenings (numbers per night)
timeFrame: Week 0 and 4
measure: Changes in sleep efficiency (percentage)
timeFrame: Week 0 and 4
measure: Changes in ADHD core symptoms (score point)
timeFrame: Week 0 and 4
measure: Changes in parental stress (score point)
timeFrame: Week 0 and 4
measure: Changes in child quality of life (score point)
timeFrame: Week 0 and 4
measure: Adverse events (Number of participants with adverse events)
timeFrame: During intervention
measure: Serious adverse events (Number of participants with serious adverse events)
timeFrame: During intervention
Other outcomes:
measure: Changes in sensory modulation disorder (score point)
timeFrame: Week 0 and 4
measure: Cost effectiveness
timeFrame: Week 0 and 4
measure: Changes in functional impairment
timeFrame: 2 years after end of treatment.
measure: Changes in ADHD core symptoms (score point)
timeFrame: 2 years after end of treatment.
measure: Changes in parental stress (score point)
timeFrame: 2 years after end of treatment.
measure: Changes in child quality of life (score point)
timeFrame: 2 years after end of treatment.
measure: Cost effectiveness
timeFrame: 2 years after end of treatment.
Locations:
city: Frederiksberg
country: Denmark
facility: The Parker Institute, Bispebjerg and Frederiksberg Hospital
Study officials:
affiliation: Research Unit for Dietary Studies, The Parker Institute
name: Ina O. Specht, Ph.d.
role: PRINCIPAL_INVESTIGATOR
References: