~4 spots leftby Mar 2026

Weighted Blankets for Dementia-Related Agitation

Recruiting in Palo Alto (17 mi)
Overseen byJanette C Leal, M.D
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Mayo Clinic
No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this research study is to determine whether the use of weighted blankets help reduce behavioral and psychological symptoms, including agitation in people with dementia.

Eligibility Criteria

This trial is for patients with dementia who are experiencing agitation. They must be in a geriatric psychiatry unit, complex interventions unit, internal medicine service or admitted hospice GIP. A documented diagnosis of dementia and a certain level of aggression on the CMAI scale are required. Patients need someone legally authorized to consent on their behalf.

Inclusion Criteria

If you have a certain level of aggressive behavior based on a specific questionnaire, you may not be able to participate.
I am admitted for geriatric psychiatry, complex care, internal medicine, or hospice.
You have been diagnosed with severe memory or thinking problems.
+1 more

Exclusion Criteria

Using a weighted blanket will likely worsen my severe pain.
I have skin burns or open wounds.
I cannot remove a blanket by myself.
+1 more

Participant Groups

The study is testing if using weighted blankets can help calm people with dementia and reduce symptoms like agitation. Participants will use these blankets to see if there's an improvement in their behavior compared to usual care without them.
2Treatment groups
Experimental Treatment
Active Control
Group I: Weighted Blanket CohortExperimental Treatment1 Intervention
Subjects will receive weighted blanket for three nights with monitoring by nurse. Weight of blanket is determined by weight of the patient (10% of patients body weight).
Group II: Control CohortActive Control1 Intervention
Subjects will receive treatment as usual while inpatient, no blanket.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?

Mayo ClinicLead Sponsor

References