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

NCT ID
NCT07588659
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
University Hospital Bispebjerg and Frederiksberg
Conditions
ADHD - Attention Deficit Disorder With Hyperactivity

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Retail-Grade Weighted Blanket Effectiveness on ADHD-related Sleep Disturbances - The Sweet BEAD Trial

Enrollment: 100 participants (Estimated).

What is being studied

  • Device: Sleep Intervention with weighted device

Who may be eligible

Ages
5 Years to 12 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: 1. Signed informed consent. 2. Age 5-12 years. 3. Diagnosis of ADHD according to ICD-10 code F90.0, F90.1, F90.9 or F98.8. 4. Participated in a usual care sleep hygiene program managed by clinicians within 6 months prior to enrollment. 5. If on ADHD medication or/and melatonin/sleep medication the dose must be stable, at least two weeks prior to enrollment. 6. The child and caregiver have adequate mastery of the Danish language. Exclusion Criteria: 1. Have used any type of weighted blanket within a 3-month period. 2. Any diagnosed diseases that markedly compromises the participant's ability to adhere to the intervention (like severe or deep mental retardation, severe underweight, chronic respiratory or circulatory conditions, surgical implants, osteoporosis). 3. Another member of the household currently or previously enrolled in the Sweet Dreams Trial or the Sweet BEAD trial.

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: Denmark

Sample of listed locations

  • Bispebjerg and Frederiksberg Hospital, The Parker Institute — Frederiksberg, 2000, Denmark — Recruiting

Study details

Start date
August 5, 2026
Primary completion date
April 30, 2027
Completion date
May 1, 2029
First posted
May 15, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07588659
Registry last updated
August 14, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07588659 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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