Weighted Blankets for Sleep Disturbance Among Children With ADHD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2028-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Attention-deficit Hyperactivity Attention Deficit Hyperactivity Disorder Neurodevelopmental Disorders Sleep Disturbance Attention Deficit Disorder Hyperkinetic Conduct Disorder Attention-Deficit Hyperactivity Disorder, Unspecified Type

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Weighted blanket

The intervention group will receive a weighted blanket classified as a medical device class 1 as an add on to usual treatment.

Group Type EXPERIMENTAL

Weighted blanket

Intervention Type DEVICE

The intervention group will receive a weighted blanket classified as a medical device class 1 as an add on to usual treatment. Participants will be asked to choose one out of at least three different weighted blankets, each with different weight classes. The choice of weighted blanket is solely taken by the participant after having tried all five blankets.

Adherence to the weighted blanket intervention is defined as reported use 60 % of the intervention period.

Usual treatment as part of standard care for children with ADHD, which can consist of sleep hygiene, psychoeducation, cognitive behavioral theory, medications such as melatonin or ADHD medication.

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.

Group Type SHAM_COMPARATOR

Non-weighted blanket

Intervention Type DEVICE

The control comparator will receive a sham intervention in the form of a non-weighted blanket as an add on to usual care. Participants will be asked to choose one out of two different sham blankets.

Usual treatment as part of standard care for children with ADHD, which can consist of sleep hygiene, psychoeducation, cognitive behavioral theory, medications such as melatonin or ADHD medication.

Interventions

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Weighted blanket

The intervention group will receive a weighted blanket classified as a medical device class 1 as an add on to usual treatment. Participants will be asked to choose one out of at least three different weighted blankets, each with different weight classes. The choice of weighted blanket is solely taken by the participant after having tried all five blankets.

Adherence to the weighted blanket intervention is defined as reported use 60 % of the intervention period.

Usual treatment as part of standard care for children with ADHD, which can consist of sleep hygiene, psychoeducation, cognitive behavioral theory, medications such as melatonin or ADHD medication.

Intervention Type DEVICE

Non-weighted blanket

The control comparator will receive a sham intervention in the form of a non-weighted blanket as an add on to usual care. Participants will be asked to choose one out of two different sham blankets.

Usual treatment as part of standard care for children with ADHD, which can consist of sleep hygiene, psychoeducation, cognitive behavioral theory, medications such as melatonin or ADHD medication.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No