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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Weighted Blanket 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 in vocalizations after using the blanket. This indicates that weighted blankets could be a promising non-drug option for managing certain symptoms of dementia. ^{1 2 3 4 5}

Is using a weighted blanket safe for people with dementia?

The use of weighted blankets in people with dementia has been explored as a non-drug treatment option, and no safety concerns were reported in the study. This suggests that weighted blankets may be a safe option for managing symptoms like agitation in dementia. ^{1 6 7 8 9}

How does the weighted blanket treatment differ from other treatments for dementia-related agitation?

Weighted blankets offer a unique, non-drug approach to managing dementia-related agitation by providing gentle pressure that can help calm and soothe individuals, unlike medications that often have side effects. This method is particularly novel as it is non-pharmacological and has shown promise in reducing persistent vocalizations in late-stage dementia. ^{1 2 7 10 11}

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.

Research Team

Maria I Lapid, MD

Principal Investigator

Mayo Clinic

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.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

The use of weighted blankets as a novel approach for treatment of persistent vocalizations in late stage dementia. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Nonpharmacological therapeutic techniques to decrease agitation in geriatric psychiatric patients with dementia. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

How sweet the sound: research evidence for the use of music in Alzheimer's dementia. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A feasibility study of Dreampad™ on sleep, wandering and agitated behaviors in people living with dementia. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of the BACE intervention on agitation of people with dementia. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial Examining the Effect of Acupressure on Agitation and Salivary Cortisol in Nursing Home Residents with Dementia. [2018]

7. England pubmed.ncbi.nlm.nih.gov

"Mãos de Conforto" (Hands of Comfort): A novel non-pharmacological intervention to ease agitation in elderly persons with dementia. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Do Warmed Blankets Change Pain, Agitation, Mood or Analgesic Use Among Nursing Home Residents? [2020]

9. England pubmed.ncbi.nlm.nih.gov

A pragmatic, multicentre, double-blind, placebo-controlled randomised trial to assess the safety, clinical and cost-effectiveness of mirtazapine and carbamazepine in people with Alzheimer's disease and agitated behaviours: the HTA-SYMBAD trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

The effects of slow-stroke back massage on minutes of nighttime sleep in persons with dementia and sleep disturbances in the nursing home: a pilot study. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Preventing agitated behaviors during bath time. [2019]