Controlled Study of Chain Blanket for Insomnia

NCT03546036 | Completed

• 1 other identifier: 2015/102-31/2
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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

Insomnia

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI)

  Self-report rating scale assessing the severity of insomnia symptoms. Range 0-28 with higher scores indicating a more severe insomnia

  Change from start to 4 weeks use of the blanket.

Secondary Outcomes (5)

• Fatigue Symptom Inventory (FSI)

  Change from start to 4 weeks use of the blanket.

• Actigraphy

  Change from start to 4 weeks use of the blanket. .

• "Day and night diaries", developed by Assistive technology Stockholm for the evaluation of weighted blankets

  Change from start to 4 weeks use of the blanket in patient estimated time (minutes) from going to bed to sleep onset.

• Hospital Anxiety and Depression Scale (HAD).

  Change from start to 4 weeks use of the blanket.

• Insomnia Severity Index (ISI)

  Change from start to 8 weeks, 6 and 12 months use of the blanket

Study Arms (2)

Weighted metal chain blanket

EXPERIMENTAL

As experimental intervention, a weighted metal chain blanket of 8 kg was used during the night. Using a flexible dose protocol, participants who found the 8 kg blanket too heavy were allowed to change to a 6 kg weighted blanket (see below)

Device: Weighted metal chain blanket

Control plastic chain blanket

SHAM COMPARATOR

As sham comparator, light chain blankets were used, were plastic chains of the same shape and size as the metal chains in the weighted blanket were sewn in. The control blanket has a weight of 1535 grams. When checking the weight of standard blankets for sale in one of the largest stores in Stockholm, weight was ranging from 550 to 2389 grams (average 1332).

Device: Control plastic chain blanket

Interventions

Weighted metal chain blanket DEVICE

Use of a weighted metal chain blanket of 8 kg

Weighted metal chain blanket

Control plastic chain blanket DEVICE

A blanket with light plastic chains

Control plastic chain blanket

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical insomnia for more than two months with a score over 14 points at the Insomnia Severity Index (ISI)1 and a diagnosis of either major depressive disorder, bipolar disorder, Generalized Anxiety disorder (GAD) or ADHD.

You may not qualify if:

• active drug abuse,
• overuse of sleep medication,
• illness affecting cognitive functions, such as dementia, schizophrenia, developmental disorders, Parkinson's disease or an acquired brain injury.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Psykiatri Sydväst, Huddinge sjukhus

Stockholm, Stockholm County, SE-14186, Sweden

Location

Related Publications (1)

• Ekholm B, Spulber S, Adler M. A randomized controlled study of weighted chain blankets for insomnia in psychiatric disorders. J Clin Sleep Med. 2020 Sep 15;16(9):1567-1577. doi: 10.5664/jcsm.8636.

  PMID: 32536366 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Mats Adler, M.D. Ph.D.

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study participants were kept blind to treatment allocation by the information that they would be assigned to one of two types of chain blanket, without any information of the difference in weight. The outcome assessor and investigator did not participate in randomization and treatment and were blind to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomization to intervention or control parallell groups on a 50/50 basis.

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: June 6, 2018
• Study Start: March 4, 2015
• Primary Completion: July 7, 2017
• Study Completion: June 20, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

SE (1)