Controlled Study of Chain Blanket for Insomnia

Insomnia Clinical Trial

Official title:

Kontrollerad Studie av Behandling Med kedjetäcken Mot sömnstörning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03546036
• Other study ID #: 2015/102-31/2
• Status: Completed
• Phase: N/A
• Start date: March 4, 2015
• Est. completion date: June 20, 2018

Study information

• Verified date: July 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Insomnia is a common and problematic symptom in many psychiatric disorders. The aim of this study is to evaluate the effect of weighted chain blankets on insomnia and other sleep-related symptoms for patients with Major depressive disorder, Bipolar disorder, Generalized Anxiety Disorder (GAD) and/or ADHD. Potential participants are asked to participate in a study comparing two different types of chain blankets, not mentioning the difference in weight. After signing a informed consent, participants were randomly assigned on a 50/50 basis to a weighted blanket containing metal chains weighing 8 kg or a control blanket containing plastic chains weighing 1,5 kg. Insomnia severity is assessed before and weekly until endpoint at four weeks use of the blanket by a rater blind to treatment allocation. Participants sleep will also be monitored by actigraphy. The controlled phase of the study is followed by a one year open follow up study where all participants are offered to use a weighted blanket of any type.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: June 20, 2018
• Est. primary completion date: July 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• Weighted metal chain blanket
Use of a weighted metal chain blanket of 8 kg
• Control plastic chain blanket
A blanket with light plastic chains

Locations

Country	Name	City	State
Sweden	Psykiatri Sydväst, Huddinge sjukhus	Stockholm	Stockholms Län

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fatigue Symptom Inventory (FSI)	Self-report symptom rating scale for daytime fatigue symptoms. Range 0-130 with higher scores indicating a more severe fatigue.	Change from start to 4 weeks use of the blanket.
Secondary	Actigraphy	An actigraph attached to the arm of the participants on the week before the intervention and during the fourth (last) week of the intervention assessing sleep by interpretation of movement	Change from start to 4 weeks use of the blanket. .
Secondary	"Day and night diaries", developed by Assistive technology Stockholm for the evaluation of weighted blankets	Self reported time to sleep onset.	Change from start to 4 weeks use of the blanket in patient estimated time (minutes) from going to bed to sleep onset.
Secondary	Hospital Anxiety and Depression Scale (HAD).	HAD is a self report rating scale for anxiety and depression symptoms.The HAD is subdivided into subscales for depressive symptoms (HAD-D) and anxiety symptoms (HAD-A), with a range of 0-21 for each subscale. Higher scores indicates more severe symptoms.	Change from start to 4 weeks use of the blanket.
Secondary	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 8 weeks, 6 and 12 months use of the blanket