DementiaNCT03643991
Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets
A study testing Weighted Blanket in people with Dementia, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Weighted Blanket
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2018to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted on the inpatient geriatric psychiatry unit, complex interventions unit, internal medicine service and/or admitted hospice GIP
- Documented diagnosis of dementia or suspected major neurocognitive disorder.
- Presence of agitation/aggression symptoms as defined by a minimum aggression score on the Cohen-Mansfield Agitation Inventory Short Version (CMAI): Patients must score 3, 4, or 5 on at least one question related to aggression (items 1-4).
- Have a LAR able to sign the consent on behalf of the patient.
Who cannot join
- Severe pain likely to be exacerbated by use of weighted blanket
- Inability to remove blanket;
- Skin burns or open wounds;
- Admitted on 72 hour hold.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets: A Pilot Study
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.
Read the detailed description
The Intervention Group
- Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained.
- Nursing staff will complete baseline assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.
- A weighted blanket, based on admission body weight, will be provided to the patient under nursing supervision.
- For 3 consecutive days after each use of weighted blanket, nursing staff will complete morning assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.
- At the end of the intervention, nursing staff will complete post-intervention assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.
Control Group:
- Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained.
- The study team will recruit a group of patients with similar characteristics as described in the inclusion criteria; however, the patient will not receive the weighted blanket, but undergo the same assessments as described in 1-5 (above) and in the Schedule of Assessments.
- Conditions
- Dementia
- Being tested
- Weighted Blanket
- Keywords
- Agitation, Dementia, Inpatient
- Medical subject headings
- Dementia, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weighted BlanketOther
Weighted blanket will be given to patients based on the patient weight (10% of patients body weight) for three nights while on inpatient unit.
| Study group | Role | What they receive |
|---|---|---|
| Weighted Blanket Cohort | Experimental | 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). Receives: Other: Weighted Blanket |
| Control Cohort | No intervention | Subjects will receive treatment as usual while inpatient, no blanket. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohen-Mansfield Agitation Inventory Short Version (CMAI) Change
Assess the agitation/aggression outcome using numeric scales ranging from 1-5. The sum of the scores is defined as the agitation/aggression outcome and ranges from 14-70, with the lower score being the better outcome.
Measured: At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket
Secondary outcomes (2)
The revised Edmonton Symptom Assessment System Revised (ESAS-r) Change
Assessment of symptoms in palliative patients using numeric analog scales ranging from 0 to 10 to assess levels of pain, tiredness, drowsiness, nausea, appetite, shortness of breath, depression, anxiety, and well-being. The sum of the scores for all symptoms is defined as the symptom distress score. The range of the sum is 0-100, with a lower score indicating a better outcome. The ESAS-r is a validated tool and publicly available for use.
Measured: At baseline and within 72 hours of the last use of the weighted blanket.
Clinical Global Impressions (CGI)
Aggression/Agitation as a measure of the global clinical outcome using a numeric scale ranging from 1-7, with a lower score indicating a better outcome.
Measured: At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start11 Apr 2018
- Primary completion28 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled patients will be computer randomized in 1:1 ratio to either the intervention group or the control group.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria I. Lapid, M.D., Mayo Clinic
- Investigators
- Maria Lapid, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643991
- Sponsor's protocol ID
- 17-009951
- Status last verified
- Dec 2025
- First submitted
- 20 Aug 2018
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schenzel HA, Palmer AK, Shah NB, Lawson DK, Fischer KM, Lapid MI, DeFoster RE. Weighted Blankets for Agitation in Hospitalized Patients with Dementia: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Feb 26;14:e57264. doi: 10.2196/57264.
PubMed 40009836
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets: A Pilot Study
- ClinicalTrials.gov ID
- NCT03643991
- Acronym / sponsor ID
- 17-009951
- Conditions
- Dementia
- Keywords
- Agitation, Dementia, Inpatient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Intervention Group
- Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained.
- Nursing staff will complete baseline assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.
- A weighted blanket, based on admission body weight, will be provided to the patient under nursing supervision.
- For 3 consecutive days after each use of weighted blanket, nursing staff will complete morning assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.
- At the end of the intervention, nursing staff will complete post-intervention assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.
Control Group:
- Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained.
- The study team will recruit a group of patients with similar characteristics as described in the inclusion criteria; however, the patient will not receive the weighted blanket, but undergo the same assessments as described in 1-5 (above) and in the Schedule of Assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Enrolled patients will be computer randomized in 1:1 ratio to either the intervention group or the control group.
| Arm | Type | Receives |
|---|---|---|
| Weighted Blanket Cohort | Experimental | Other: Weighted BlanketSubjects 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). |
| Control Cohort | No intervention | –Subjects will receive treatment as usual while inpatient, no blanket. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients admitted on the inpatient geriatric psychiatry unit, complex interventions unit, internal medicine service and/or admitted hospice GIP
- Documented diagnosis of dementia or suspected major neurocognitive disorder.
- Presence of agitation/aggression symptoms as defined by a minimum aggression score on the Cohen-Mansfield Agitation Inventory Short Version (CMAI): Patients must score 3, 4, or 5 on at least one question related to aggression (items 1-4).
- Have a LAR able to sign the consent on behalf of the patient.
Key exclusion criteria (4 listed)
- Severe pain likely to be exacerbated by use of weighted blanket
- Inability to remove blanket;
- Skin burns or open wounds;
- Admitted on 72 hour hold.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weighted BlanketWeighted blanket will be given to patients based on the patient weight (10% of patients body weight) for three nights while on inpatient unit. | Other | Weighted Blanket Cohort |
Primary outcome
Cohen-Mansfield Agitation Inventory Short Version (CMAI) Change
Time frame: At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket
Assess the agitation/aggression outcome using numeric scales ranging from 1-5. The sum of the scores is defined as the agitation/aggression outcome and ranges from 14-70, with the lower score being the better outcome.
2 secondary outcomes
The revised Edmonton Symptom Assessment System Revised (ESAS-r) Change
Time frame: At baseline and within 72 hours of the last use of the weighted blanket.
Clinical Global Impressions (CGI)
Time frame: At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Derived from this study: PubMed 40009836Schenzel HA, Palmer AK, Shah NB, Lawson DK, Fischer KM, Lapid MI, DeFoster RE. Weighted Blankets for Agitation in Hospitalized Patients with Dementia: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Feb 26;14:e57264. doi: 10.2196/57264.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Lapid, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted Blanket in people with Dementia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohen-Mansfield Agitation Inventory Short Version (CMAI) Change (time frame: At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03643991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.