Controlled Study of Chain Blanket for Insomnia
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|ClinicalTrials.gov Identifier: NCT03546036|
Recruitment Status : Completed
First Posted : June 6, 2018
Last Update Posted : July 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Insomnia||Device: Weighted metal chain blanket Device: Control plastic chain blanket||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomization to intervention or control parallell groups on a 50/50 basis.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||Kontrollerad Studie av Behandling Med kedjetäcken Mot sömnstörning|
|Actual Study Start Date :||March 4, 2015|
|Actual Primary Completion Date :||July 7, 2017|
|Actual Study Completion Date :||June 20, 2018|
Experimental: Weighted metal chain blanket
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
Use of a weighted metal chain blanket of 8 kg
Sham Comparator: Control plastic chain blanket
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
A blanket with light plastic chains
- Insomnia Severity Index (ISI) [ Time Frame: Change from start to 4 weeks use of the blanket. ]Self-report rating scale assessing the severity of insomnia symptoms. Range 0-28 with higher scores indicating a more severe insomnia
- Fatigue Symptom Inventory (FSI) [ Time Frame: Change from start to 4 weeks use of the blanket. ]Self-report symptom rating scale for daytime fatigue symptoms. Range 0-130 with higher scores indicating a more severe fatigue.
- Actigraphy [ Time Frame: Change from start to 4 weeks use of the blanket. . ]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
- "Day and night diaries", developed by Assistive technology Stockholm for the evaluation of weighted blankets [ Time Frame: Change from start to 4 weeks use of the blanket in patient estimated time (minutes) from going to bed to sleep onset. ]Self reported time to sleep onset.
- Hospital Anxiety and Depression Scale (HAD). [ Time Frame: Change from start to 4 weeks use of the blanket. ]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.
- Insomnia Severity Index (ISI) [ Time Frame: Change from start to 8 weeks, 6 and 12 months use of the blanket ]Self-report rating scale assessing the severity of insomnia symptoms. Range 0-28 with higher scores indicating a more severe insomnia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546036
|Psykiatri Sydväst, Huddinge sjukhus|
|Stockholm, Stockholms Län, Sweden, SE-14186|
|Principal Investigator:||Mats Adler, M.D. Ph.D.||Karolinska Institutet|