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NCT05963607 · ClinicalTrials.gov registry record · NA
RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain
A NA study of Chronic Pain and Sleep Disturbance, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 160
- Enrollment target
- 3
- Study locations
NCT05963607: Recruiting NA study of Chronic Pain and Sleep Disturbance, sponsored by VA Office of Research and Development.
NCT05963607 is a NA study of Chronic Pain and Sleep Disturbance that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 160 participants, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (79% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05963607, a NA study of Chronic Pain and Sleep Disturbance, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 160 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Primary Outcome
Pain impact (severity and interference) will be measured by the Pain, Enjoyment of Life, and General Activity (PEG) Scale
Conditions Studied
Interventions
- OTHER Weighted blanket
Study Locations (3)
California
- VA San Diego Healthcare System, San Diego, CA - San Diego
- VA San Diego Healthcare System, San Diego, CA - San Diego
- San Francisco VA Medical Center, San Francisco, CA - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2029-09-30 |
| Phase | NA |
What NCT05963607 shows while recruiting
NCT05963607 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (79% lower).
The record links to 2 conditions, with Chronic Pain appearing as the primary indexed condition, and to 1 intervention - of which Weighted blanket is the first listed.
NCT05963607 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05963607 about?
NCT05963607 is a clinical study titled "RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain". 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 di...
What is the current status of trial NCT05963607?
This trial is currently recruiting. It is a NA study. The enrollment target is 160 participants. The study started on 2024-08-01. Estimated completion is 2029-09-30.
What conditions does trial NCT05963607 study?
This clinical trial studies the following conditions: Chronic Pain, Sleep Disturbance.
What interventions are being tested in trial NCT05963607?
The interventions under investigation include: Weighted blanket (OTHER).
Who is sponsoring clinical trial NCT05963607?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05963607 being conducted?
This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05963607's enrollment target sits among peer trials
160 97th of 301 higher than 203 of 301 other Chronic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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