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Controlled Study of Chain Blanket for Insomnia

NCT03546036 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2018-07-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Weighted metal chain blanket

Use of a weighted metal chain blanket of 8 kg

DEVICE

Control plastic chain blanket

A blanket with light plastic chains

Sponsors & Collaborators

Principal Investigators

  • Mats Adler, M.D. Ph.D. · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-04
Primary Completion
2017-07-07
Completion
2018-06-20

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03546036 on ClinicalTrials.gov