Last reviewed · How we verify
NCT05963607: WB
RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain
NA trial testing Weighted blanket in Chronic Pain in 160 participants. Currently enrolling.
1 April 2029
Quick facts
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 160 |
| Start date | 1 August 2024 |
| Primary completion | 1 April 2029 |
| Estimated completion | 30 September 2029 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Weighted blanket
Conditions studied
- Chronic Pain — all drugs for Chronic Pain →
- Sleep Disturbance — all drugs for Sleep Disturbance →
Sponsor
VA Office of Research and Development — full company profile →
Who can join
18 and older, any sex, with Chronic Pain or Sleep Disturbance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Chronic pain is a major health concern for returning Veterans and is associated with decreases in quality of life. In addition, chronic pain is often accompanied by significant disturbance in sleep. Sensory interventions may offer effective, low-cost complementary tools for chronic pain and sleep disturbance in Veterans. Weighted Blankets (WB)- blankets sewn with weighted material inside to provide widespread pressure to the body- are a low-cost wellness product used for anxiety and sleep. WBs have demonstrated large reductions in insomnia, and the investigators have also shown that they can reduce the severity of chronic pain. However, effects and mechanisms of longer WB use have not been examined in individuals with pain and sleep disturbance. The investigators therefore propose a randomized controlled trial examining the effects of WBs on pain and sleep quality in Veterans. the investigators will recruit Veterans with chronic pain and sleep disturbance from the VA San Diego Healthcare System (VASDHS) and VA San Francisco Healthcare System (VASFHS) and randomize 160 Veterans to receive either a light (3-lb; N = 80) or heavy (15-lb; N = 80) blanket. The investigators will remotely collect measures of pain (primary), pain catastrophizing, and pain medication use, as well as sleep disturbance (primary) and sleep efficiency and total sleep time over 6 weeks of overnight home use of the assigned blanket. The investigators will also explore physiological effects of WBs on sleep quality using actigraphy (exploratory) in VASDHS participants. Ecological momentary assessment (EMA) methods will be deployed via smartphone to capture study adherence.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05963607
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Weighted blanket
Trials testing the same drug.
- NCT06194162 — Weighted Blankets for Sleep Disturbance Among Children With ADHD · NA · recruiting
- NCT05632640 — Post Anesthesia Care Unit (PACU) Weighted Blanket Study · NA · completed
- NCT04191720 — Assessing the Impact of Weighted Blankets on Anxiety Among Inpatients With Anorexia Nervosa: a Study Protocol · NA · completed
Other recruiting trials for Chronic Pain
Currently open trials in the same condition.
- NCT07491549 — The Effect of Pain Education Group Therapy and Its Impact on Chronic Pain, Kinesiophobia, and Physical Activity · NA · recruiting
- NCT07425691 — SPACE for Youth With Chronic Pain · recruiting
- NCT07103135 — Optimizing Accelerated TMS for Chronic Pain With Thompson Sampling · Phase 1 · recruiting
- NCT06219408 — CIH Stepped Care for Co-occurring Chronic Pain and PTSD · NA · recruiting
- NCT07270406 — Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain · NA · recruiting
Other VA Office of Research and Development trials
Trials by the same sponsor.
- NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care · Phase 1 · not yet recruiting
- NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran · NA · not yet recruiting
- NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness · NA · not yet recruiting
- NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans · NA · not yet recruiting
- NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05963607 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
- Last refreshed: 30 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05963607.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing