NCT06194162 is a NA clinical trial of Weighted blanket in Attention-deficit Hyperactivity, sponsored by University Hospital Bispebjerg and Frederiksberg.

Who is sponsoring NCT06194162?

NCT06194162 is sponsored by University Hospital Bispebjerg and Frederiksberg.

What drugs are being tested in NCT06194162?

Interventions in NCT06194162: Weighted blanket, Non-weighted blanket.

What condition does NCT06194162 study?

NCT06194162 studies Attention-deficit Hyperactivity, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders, Sleep Disturbance, Attention Deficit Disorder, Hyperkinetic Conduct Disorder, Attention-Deficit Hyperactivity Disorder, Unspecified Type.

Is NCT06194162 still recruiting?

NCT06194162 is currently recruiting now. Last updated 17 January 2024.

Last reviewed 2024-01-17 · How we verify

NCT06194162

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Weighted Blankets for Sleep Disturbance Among Children With ADHD

Recruiting now NA Last updated 17 January 2024

What this trial tests

NA trial testing Weighted blanket in Attention-deficit Hyperactivity in 340 participants. Currently enrolling.

Timeline

1 January 2024

Primary endpoint
15 April 2026

1 August 2028

Quick facts

Lead sponsor	University Hospital Bispebjerg and Frederiksberg
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	340
Start date	1 January 2024
Primary completion	15 April 2026
Estimated completion	1 August 2028
Sites	1 location across Denmark

Drugs / interventions tested

Weighted blanket
Non-weighted blanket

Conditions studied

Attention-deficit Hyperactivity — all drugs for Attention-deficit Hyperactivity →
Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →
Neurodevelopmental Disorders — all drugs for Neurodevelopmental Disorders →
Sleep Disturbance — all drugs for Sleep Disturbance →

Sponsor

University Hospital Bispebjerg and Frederiksberg

Who can join

Adults 5 to 12, any sex, with Attention-deficit Hyperactivity or Attention Deficit Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Impact of weighted blankets on sleep disturbance among children with attention deficit hyperactivity disorders (ADHD): study protocol for a pragmatic randomised controlled trial.
Rohde JF, Ginnerup-Nielsen E, Larsen SC, Tjott C, et al · · 2025 · PMID 40200167 · DOI 10.1186/s12888-025-06768-6

Verify or expand the search:

Other trials of Weighted blanket

Trials testing the same drug.

NCT05963607 — RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain · NA · recruiting
NCT05632640 — Post Anesthesia Care Unit (PACU) Weighted Blanket Study · NA · completed
NCT04191720 — Assessing the Impact of Weighted Blankets on Anxiety Among Inpatients With Anorexia Nervosa: a Study Protocol · NA · completed

Other University Hospital Bispebjerg and Frederiksberg trials

Trials by the same sponsor.

NCT07060586 — The Effect of Sphenopalatine Ganglion Block on Headache and Vasalgia · NA · completed
NCT06911411 — PALLIATIVE ASSESSMENT COHORT IN THE GERIATRIC EMERGENCY SETTING · not yet recruiting
NCT06405750 — Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate · NA · recruiting
NCT06532825 — Cardiac Autonomic Dysfunction As a Sign of Irreversible Advanced Heart Failure · recruiting
NCT06184581 — Lithium Versus Lamotrigine in Bipolar Disorder, Type II · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06194162 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital Bispebjerg and Frederiksberg
Last refreshed: 17 January 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06194162.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing