NCT03546036 is a NA clinical trial of Weighted metal chain blanket in Insomnia, sponsored by Karolinska Institutet.

Who is sponsoring NCT03546036?

NCT03546036 is sponsored by Karolinska Institutet.

What drugs are being tested in NCT03546036?

Interventions in NCT03546036: Weighted metal chain blanket, Control plastic chain blanket.

Is NCT03546036 still recruiting?

NCT03546036 is currently completed. Last updated 17 July 2018.

Last reviewed 2018-07-17 · How we verify

NCT03546036

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

Controlled Study of Chain Blanket for Insomnia

Completed NA Last updated 17 July 2018

What this trial tests

NA trial testing Weighted metal chain blanket in Insomnia in 119 participants. Completed in 20 June 2018.

Timeline

4 March 2015

Primary endpoint
7 July 2017

20 June 2018

Quick facts

Lead sponsor	Karolinska Institutet
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	119
Start date	4 March 2015
Primary completion	7 July 2017
Estimated completion	20 June 2018
Sites	1 location across Sweden

Drugs / interventions tested

Weighted metal chain blanket
Control plastic chain blanket

Conditions studied

Insomnia — all drugs for Insomnia →

Sponsor

Karolinska Institutet

Who can join

18 and older, any sex, with Insomnia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of the study is to compare an intervention with a weighted metal chain blanket of 8 kg with a control plastic chain blanket of 1,5 kg for patients with Major depressive disorder, bipolar disorder, Generalized Anxiety Disorder (GAD) and/or attention deficit hyperactivity disorder (ADHD) and co-occurring insomnia. Patients are evaluated by a rater blind to treatment allocation with Insomnia Severity Index (ISI), Fatigue Symptom Inventory (FSI), Hospital Anxiety and Depression Scale (HAD) and actigraphy before, during and at primary end-point after 4 weeks use of the blanket.

Publications & conference data

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

A randomized controlled study of weighted chain blankets for insomnia in psychiatric disorders.
Ekholm B, Spulber S, Adler M. · · 2020 · cited 42× · PMID 32536366 · DOI 10.5664/jcsm.8636

Verify or expand the search:

Other recruiting trials for Insomnia

Currently open trials in the same condition.

NCT07384429 — Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease · Phase 4 · recruiting
NCT07270406 — Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain · NA · recruiting
NCT07071324 — CF Wellness Program · NA · recruiting
NCT07417813 — A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders · recruiting
NCT06348082 — Project Women's Insomnia Sleep Health Equity Study (WISHES) · NA · recruiting

Other Karolinska Institutet trials

Trials by the same sponsor.

NCT06359262 — Evaluating the Hope@School Prevention Program · NA · not yet recruiting
NCT07289490 — Bilateral vs Unilateral Inguinal Hernia Repairs With an Asymptomatic Inguinal Hernia in Bilateral Hernias · NA · not yet recruiting
NCT06894264 — Emotion Processing and Regulation in People With Intellectual Disability · NA · not yet recruiting
NCT07494266 — Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited · NA · not yet recruiting
NCT07442032 — Cardiovascular Phenotypes in Sepsis · not yet 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 NCT03546036 (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 Karolinska Institutet
Last refreshed: 17 July 2018

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/NCT03546036.

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