Could a weighted blanket help ICU patients breathe easier off the ventilator?
NCT ID NCT07710469
First seen Jul 17, 2026 · Last updated Aug 11, 2026 · Updated 2 times
Summary
This study tests whether a specially designed weighted blanket can improve sedation quality and comfort for ICU patients being weaned off a breathing machine. Participants are randomly assigned to receive either the weighted blanket or standard linens during weaning. The blanket is adjustable in weight and placement to fit individual needs. The goal is to see if it helps patients stay calmly alert and reduces agitation without extra medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a hospital-grade weighted blanket designed for ICU use, with adjustable weight and configuration
- What this could lead to
- If effective, this blanket could offer a simple, non-drug way to reduce anxiety and agitation during ventilator weaning, potentially improving patient comfort and outcomes.
- What could go wrong
- This is a small, early-stage trial with only 64 participants, so results may not apply broadly. The blanket may be rejected by patients or clinicians, or may not improve sedation quality significantly.
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 64 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years * Intubated and mechanically ventilated * Receiving sedation and/or analgesia * Documented clinical decision to initiate ventilator weaning * Patient or legally authorized representative (LAR)/healthcare proxy (HCP) able to provide informed consent Exclusion Criteria: * Conditions in which deep pressure / blanket application may compromise safety in the opinion of the treating clinical team * Braden Scale score ≤9 with evidence of significant skin compromise * Patients with pre-existing pressure injuries on posterior, weight-bearing body surfaces (e.g., sacrum, coccyx, heels) will be excluded * Recent major surgery or unstable fractures affecting the torso * Continuous prone positioning * Body mass index ≥35 kg/m² as a precautionary exclusion due to uncertainty regarding pressure distribution and respiratory mechanics during early feasibility testing * Concurrent enrollment in another interventional trial affecting sedation or ventilation * Anticipated withdrawal of life-sustaining therapy * Pregnant individuals in the 2nd or 3rd trimester
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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
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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