Retail-Grade Weighted Blanket Effectiveness on ADHD-related Sleep Disturbances (BEAD)

Summary

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.

Conditions

• ADHD - Attention Deficit Disorder With Hyperactivity

Interventions

DEVICE

Sleep Intervention with weighted device

The use of retail-grade weighted blanket among children with ADHD and sleep disturbances aged 5-12 years.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg

  lead OTHER

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

5 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-20

Primary Completion

2027-04-30

Completion

2029-05-31