Decreasing Agitation in Patients with Dementia Through the Use of Weighted Blankets


  • Study type

  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-009951
    NCT ID: NCT03643991
    Sponsor Protocol Number: 17-009951

About this study

The purpose of this study is to reduce behaviors and psychotic symptoms of dementia by using a weighted blanket as a non-pharmacological method to decrease agitation and distress in the elderly population.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  1. Patients admitted on the inpatient geriatric psychiatry unit, age 60 years and older
  2. Diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria
  3. Presence of agitation/aggression symptoms as defined by a minimum aggression score on the Cohen-Mansfield Agitation Inventory Short Version (CMAI): a score ≥ 4 on at least one aggressive item

Exclusion Criteria: 

  1. Inability to remove blanket
  2. Severe pain exacerbated by use of weighted blanket
  3. Skin burns or open wounds
  4. Allergy to blanket material

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Janette Leal, M.D.

Closed-enrolling by invitation

What is this? (?)
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Monica Walton


More information


Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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