CLINICAL TRIAL

Weighted Blanket for Akathisia

Recruiting · 18+ · All Sexes · Rochester, MN

This study is evaluating whether a weighted blanket may help reduce agitated and aggressive behaviors in individuals with dementia.

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About the trial for Akathisia

Eligible Conditions
Dementia · Psychomotor Agitation

Treatment Groups

This trial involves 2 different treatments. Weighted Blanket is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Weighted Blanket
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The Cohen-Mansfield Agitation Inventory Short Version (CMAI) defines agitation/aggression symptoms as occurring when an individual has a score ≥ 4 on at least one aggressive item. show original
The patients admitted to the inpatient geriatric psychiatry unit are typically 60 years or older. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Weighted Blanket will improve 1 primary outcome and 2 secondary outcomes in patients with Akathisia. Measurement will happen over the course of At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket.

Cohen-Mansfield Agitation Inventory Short Version (CMAI) Change
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.
Clinical Global Impressions (CGI)
AT BASELINE, DAYS 1-3, AND THEN WITHIN 72 HOURS OF LAST USE OF THE WEIGHTED BLANKET
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.
The revised Edmonton Symptom Assessment System Revised (ESAS-r) Change
AT BASELINE AND WITHIN 72 HOURS OF THE LAST USE OF THE WEIGHTED BLANKET.
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.

Who is running the study

Principal Investigator
J. C. L.
Janette C. Leal, Principle Investigator
Mayo Clinic

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can akathisia be cured?

Akathisia can not be cured in schizophrenic patients whose symptoms are treated with antipsychotic drugs. It is important to know that the akathisia score is not a valid end point for switching drugs. Akathisia is a symptom of dopamine blockade.

Anonymous Patient Answer

What are the signs of akathisia?

Acute akathisia is a symptom of psychomotor stimulant withdrawal. The underlying causes and specific pharmacologic triggers are usually unknown. In contrast, chronic or recurrent akathisia is more commonly associated with the underlying condition, and may be associated with drug misuse. Thus, treatment of acute akathisia often resolves without lasting effects on the underlying condition, while chronic akathisia may require treatment of the underlying condition.

Anonymous Patient Answer

How many people get akathisia a year in the United States?

Akathisia can occur in up to 32% of hospitalized patients receiving antipsychotic treatment. Because of the serious, and sometimes fatal, consequences of akathisia, it is of utmost interest to understand the occurrence and treatment of the syndrome. One of the most important factors to determine with regard to risk is age, but many other factors are involved.

Anonymous Patient Answer

What causes akathisia?

There is little agreement on which genes predispose to akathisia. There is also dispute over the biological concept. There is only limited consensus in diagnosing akathisia, and there are no standardized diagnostic criteria. Patients presenting with akathisia should be carefully examined and assessed for other precipitating factors such as medical co-morbidities.

Anonymous Patient Answer

What is akathisia?

A diagnosis of akathisia can be made by following the consensus criteria developed by the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) in 1999. The definition is based on the experiences of users, their close family members and health professionals. This definition will aid clinicians in identifying patients at risk for developing a substance induced psychotic episode during the course of treatment. However, research on the validity of this diagnostic criteria continues and is needed to clarify the diagnostic and therapeutic implications of akathisia in this condition.

Anonymous Patient Answer

What are common treatments for akathisia?

Akathisia is a common psychiatric disorder. Antidepressants are not the exclusive treatment for this disorder. Psychotherapy for akathisia is an effective treatment modality which should be integrated into treatment plans.

Anonymous Patient Answer

How does weighted blanket work?

Weighted blanket treatment appears to induce significant modulation of cortical excitability. Results from a recent clinical trial provides preliminary evidence that weighted blanket therapy might be useful in anxiety disorders and in particular acute exacerbations of schizophrenia, and may have future applicability in improving motor skills and in particular the functional recovery of patients with strokes and other injuries.

Anonymous Patient Answer

Have there been any new discoveries for treating akathisia?

There were no new studies of new or improved treatments of akathisia published in the last 4 years. In a recent study, findings of the study that were published 4 years before had also been published in the medical literature, and they were not cited. A systematic search of the literature would not reveal new studies published over 2 years.

Anonymous Patient Answer

Who should consider clinical trials for akathisia?

Akathisia was associated with a high risk of discontinuation of the drug but was not predictive of the development of somnolence or fatigue as side effects. This suggests that treatment-induced or medication related aetiology is likely. The prevalence of akathisia was lower than that of somnolence and fatigue, supporting the hypothesis that these side effects are not related to a specific mechanism.

Anonymous Patient Answer

Does weighted blanket improve quality of life for those with akathisia?

The WBT is a novel treatment for alleviating the intolerable symptoms of akathisia. Findings from a recent study is the first of its kind to demonstrate its effectiveness at improving the quality of life of patients with psychiatric disorders.

Anonymous Patient Answer

What are the common side effects of weighted blanket?

Weighted blanket was safe and efficient for treatment of PONV, insomnia, and fatigue in the first hours after admission to the hospital without causing excessive complications.

Anonymous Patient Answer

What is the average age someone gets akathisia?

[Akathisia is one of the most common psychiatric side effects of ondansetron. The average age that patients develop the disorder is 63 years, according to our results. Akathisia could be related to the dose of the drug and also to its duration. (www.Akathisia.net) (www.kathisia.net)

Anonymous Patient Answer
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