Clinical trial NCT03546036: Controlled Study of Chain Blanket for Insomnia
Official title: Kontrollerad Studie av Behandling Med kedjetäcken Mot sömnstörning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2018-06-06
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to intervention or control parallell groups on a 50/50 basis.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Change from start to 4 weeks use of the blanket.
Secondary outcomes:
measure: Fatigue Symptom Inventory (FSI)
timeFrame: Change from start to 4 weeks use of the blanket.
measure: Actigraphy
timeFrame: Change from start to 4 weeks use of the blanket. .
measure: "Day and night diaries", developed by Assistive technology Stockholm for the evaluation of weighted blankets
timeFrame: Change from start to 4 weeks use of the blanket in patient estimated time (minutes) from going to bed to sleep onset.
measure: Hospital Anxiety and Depression Scale (HAD).
timeFrame: Change from start to 4 weeks use of the blanket.
measure: Insomnia Severity Index (ISI)
timeFrame: Change from start to 8 weeks, 6 and 12 months use of the blanket
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Psykiatri Sydväst, Huddinge sjukhus
state: Stockholms Län
Study officials:
affiliation: Karolinska Institutet
name: Mats Adler, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.