Heavy blankets tested as Drug-Free pain relief for veterans
NCT ID NCT05963607
First seen Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 3 times
Summary
This study is testing whether a weighted blanket can help veterans with chronic pain and sleep problems. 160 veterans will use either a light (3-pound) or heavy (15-pound) blanket at home for 6 weeks. Researchers will track changes in pain, sleep quality, and medication use to see if the heavier blanket offers more relief.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- weighted blanket
- What this could lead to
- If it works, this could provide a simple, low-cost tool to help veterans manage chronic pain and sleep problems at home.
- What could go wrong
- This is an early-stage trial with only 160 participants. The results may not apply to all veterans, and the blanket might not provide meaningful pain relief for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: The inclusion/exclusion criteria are designed to be as inclusive as possible and to reflect the heterogeneity of "real-world" Veterans referred to usual care, to maximize generalizability: * VA-enrolled * All genders, ages 18 and older * chronic non-cancer musculoskeletal pain diagnosis on 2 clinical visits for at least 6 months (ICD codes for chronic pain), and a score of 3 on the numerical pain rating scale from 0-10 over the past week * sleep disturbance measured by a score \>= 11 on the ISI. Exclusion Criteria: Exclusion criteria: Exclusion criteria include only those factors that contraindicate usual treatment for chronic pain, that prevent the Veteran from benefiting from study treatments, or that may interfere with the mechanisms under study: * Serious or untreated mental illness (e.g., psychosis; PTSD will not be excluded), * other psychosocial instability (e.g., homelessness), or * suicidal/homicidal ideation/prior attempt within the past 3 years by the Mini-International Neuropsychiatric Interview (MINI)19; * evidence of opioid use disorder by chart review, or a Current Opioid Misuse Measure (COMM20) score of 9 or both; * major medical conditions or medical counterindications to use of a 15-lb WB (e.g., self-reported or documented current pregnancy; * claustrophobia; * spinal cord injury; * inability to safely lift 15lb); * obstructive sleep apnea if untreated, OR STOP-BANG score in "high-risk" category; and * currently sleeping with a special blanket (such as weighted or cooling blanket). * Those receiving mental health or other pain treatment will be excluded if there are changes to treatment (either therapy or medications) in the 3 months prior to enrollment or anticipated during the 2-month trial (self-report, confirmed as possible in electronic health record).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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San Francisco VA Medical Center, San Francisco, CA
RECRUITINGSan Francisco, California, 94121-1563, United States
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VA San Diego Healthcare System, San Diego, CA
RECRUITINGSan Diego, California, 92161-0002, United States
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