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Weighted Blanket Study for Chronic Pain in Veterans

This study is testing if a weighted blanket can help reduce chronic pain and improve sleep for Veterans. Chronic pain is a big problem for many Veterans and often comes with sleep problems. Researchers believe that weighted blankets, which have extra weight sewn into them to provide gentle pressure, might be a low-cost way to help with both pain and sleep. This study will look at how much your pain changes and how much your sleep improves over six weeks if you use a weighted blanket. You may be able to join if you are a Veteran, 18 or older, and have chronic non-cancer musculoskeletal pain for at least six months.

Study design
This is an interventional study planning to enroll 160 participants.
What's involved
Your pain and sleep will be measured at the start of the study, and then again at weeks 2, 4, and 6.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for six weeks after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05963607

RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain

Recruiting
NAAges 18+InterventionalTreatment
VA Office of Research and Development
~160 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Weighted blanket

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain impact change
Measured over Weeks 0, 2, 4, and 6
+1 more outcome measured

Conditions

Chronic Pain
Sleep Disturbance

Explore related trials

Chronic PainSleep Disorder

Where it's being run

2 sites across 1 states
California2

Study leadership

  • Irina Strigo, PhD · PRINCIPAL_INVESTIGATOR · San Francisco VA Medical Center, San Francisco, CA

Who to contact

Irina Strigo, PhD
[email protected]
(415) 221-4810 · ext. 25138
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Pain impact changeWeeks 0, 2, 4, and 6

    Pain impact (severity and interference) will be measured by the Pain, Enjoyment of Life, and General Activity (PEG) Scale

  • Sleep disturbance changeWeeks 0, 2, 4, and 6

    Sleep disturbance will be measured by the Insomnia Severity Index (ISI)