Weighted Blankets for Sleep Disturbance Among Children With ADHD

NCT06194162 | Recruiting

• 1 other identifier: Sweet Dreams
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Changes in total sleep time (average minutes per day)

  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).

  Week 0 and 4

Secondary Outcomes (9)

• 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 sleep efficiency (percentage)

  Week 0 and 4

• Changes in ADHD core symptoms (score point)

  Week 0 and 4

Other Outcomes (7)

• Changes in sensory modulation disorder (score point)

  Week 0 and 4

• Cost effectiveness

  Week 0 and 4

• Changes in functional impairment

  2 years after end of treatment.

Study Arms (2)

Weighted blanket

EXPERIMENTAL

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

Device: Weighted blanket

Non-weighted blanket

SHAM COMPARATOR

The control comparator group will receive a sham intervention in the form of a non-weighted blanket. as an add on to usual treatment.

Device: Non-weighted blanket

Interventions

Weighted blanket 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.

Weighted blanket

Non-weighted blanket 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.

Non-weighted blanket

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 F98.8.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead
• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: collaborator

Study Sites (1)

The Parker Institute, Bispebjerg and Frederiksberg Hospital

Frederiksberg, 2000, Denmark

RECRUITING

Related Publications (1)

• Rohde JF, Ginnerup-Nielsen E, Larsen SC, Tjott C, Christensen R, Heitmann BL, Waehrens EE, Pagsberg AK, Specht IO. Impact of weighted blankets on sleep disturbance among children with attention deficit hyperactivity disorders (ADHD): study protocol for a pragmatic randomised controlled trial. BMC Psychiatry. 2025 Apr 8;25(1):345. doi: 10.1186/s12888-025-06768-6.

  PMID: 40200167 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders; Parasomnias

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ina O. Specht, Ph.d.

  Research Unit for Dietary Studies, The Parker Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ina O. Specht, Ph.d.

CONTACT

+45 51197904; ina.olmer.specht@regionh.dk

Jeanett F. Rohde, Ph.d.

CONTACT

+45 51197904; jeanett.friis.rohde@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior reseacher

Model Details: 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).

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: January 8, 2024
• Study Start: January 1, 2024
• Primary Completion: April 15, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)