Weighted Blankets for Dementia-Related Agitation

Overseen By Monica Walton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Severe pain, Skin burns, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 73

Duration: 3 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether weighted blankets can calm people with dementia who often feel agitated or restless. Participants will either use a weighted blanket for three nights or continue with their usual care without a blanket. The goal is to determine if the blankets can reduce agitation and improve comfort. Suitable candidates include those with dementia who frequently experience agitation or aggression and are staying in a hospital or hospice.

As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance comfort and care for individuals with dementia.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, but it's best to check with the trial coordinators.

What prior data suggests that weighted blankets are safe for people with dementia?

Research has shown that weighted blankets are generally safe for people with dementia. In studies, both patients and hospital staff have accepted these blankets well. Designed to weigh about 10% of a person's body weight, most people find them comfortable.

Trials have reported no serious side effects, suggesting that weighted blankets can safely help reduce agitation and other symptoms in people with dementia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using weighted blankets for dementia-related agitation because they offer a non-pharmacological approach, unlike traditional medications that often have side effects. Typical treatments for agitation in dementia might include antipsychotics or sedatives, which can lead to drowsiness or other adverse effects. Weighted blankets provide a calming effect through deep pressure stimulation, which is believed to help reduce anxiety and agitation naturally. This approach can be especially appealing for improving the comfort and quality of life for individuals with dementia without the need for medication.

What evidence suggests that weighted blankets are effective for reducing agitation in dementia?

Research has shown that weighted blankets might help calm people with dementia. In this trial, participants in the Weighted Blanket Cohort will use a weighted blanket for three nights, monitored by a nurse. One study found that these blankets significantly reduced constant loud noises made by individuals with late-stage dementia. Another study found that weighted blankets not only lessened aggression and agitation but were also favored by both patients and staff. Additionally, these blankets have improved stress-related issues, such as sleep and anxiety, in other groups. Overall, this evidence suggests that weighted blankets could be a safe and effective way to reduce agitation in those with dementia. ^{1 3 5 6 7}

Who Is on the Research Team?

Maria I Lapid, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive a weighted blanket for three nights with monitoring by nursing staff

3 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for behavioral disturbances and distressing symptoms after the intervention

1 week

Assessments within 72 hours of last use

What Are the Treatments Tested in This Trial?

Interventions

• Weighted Blanket

Trial Overview 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.

How Is the Trial Designed?

Group I: Weighted Blanket Cohort Experimental Treatment 1 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 Cohort Active Control 1 Intervention

Subjects will receive treatment as usual while inpatient, no blanket.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11904365/

Weighted Blankets for Agitation in Hospitalized Patients ... The aim of this study is to investigate the effect of weighted blankets on aggression and agitation in hospitalized patients with dementia.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S019745722100272X

The use of weighted blankets as a novel approach for ... This study explored the use of weighted blankets as a non-pharmacological treatment for persistent vocalizations in late stage dementia.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jan.17049

Evaluating the Safety, Feasibility and Acceptability of ... This study provides evidence that weighted blankets may be used safely with the acceptance of patients with dementia and staff in hospitals.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9561070/

Feasibility and Acceptability of a Remotely Delivered ... Use of weighted blankets improved several stress-related outcomes (e.g., sleep, fatigue, depression, anxiety, physiologic stress) among non-cognitively impaired ...

5. withpower.com withpower.com/trial/phase-psychomotor-agitation-3-2018-4d6a4

Weighted Blankets for Dementia-Related Agitation Research suggests that weighted blankets may help reduce persistent vocalizations in people with late-stage dementia, as a study found a significant reduction ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40371986/

Evaluating the Safety, Feasibility and Acceptability of ... This study provides evidence that weighted blankets may be used safely with the acceptance of patients with dementia and staff in hospitals.

7. mayo.edu mayo.edu/research/clinical-trials/cls-20403059

Decreasing Agitation in Patients with Dementia Through ... The purpose of this study is to reduce behaviors and psychotic symptoms of dementia by using a weighted blanket as a non-pharmacological method.