Can sensory therapy calm Dementia-Related agitation in hospitals?
NCT ID NCT07778329
Running, but no longer taking on new participants.
First seen Aug 21, 2026 · Last updated Aug 21, 2026
Summary
This trial tests whether adding a structured psychosocial intervention—sensory and general stimulation plus caregiver education—to standard medication can reduce behavioral and psychological symptoms in older adults hospitalized with dementia or delirium. Participants over 65 with significant behavioral disturbances are randomly assigned to receive either standard pharmacological care alone or that care plus individualized stimulation sessions three times a week, with caregivers also receiving education. The study measures changes in symptom severity using the Neuropsychiatric Inventory, aiming to see if this non-drug approach can improve outcomes and support caregivers.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Sensory and general stimulation (Snoezelen-based) with caregiver education
- What this could lead to
- If effective, this approach could offer a drug-free way to reduce distressing behavioral symptoms in hospitalized dementia patients, potentially improving outcomes and easing caregiver burden.
- What could go wrong
- This is a single-center trial with a modest sample size, and results may not apply broadly. The intervention's success depends on staff training and individual patient response, and it may not outperform standard care.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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132 people
The number who actually took part.
- Started
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Sep 2021
- Expected to finish
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Aug 2026
An estimate. End dates often move.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age older than 65 years. * Diagnosis of dementia and/or delirium. * Availability of a caregiver who also assists the participant at home and is willing to participate in the caregiver education program. * Presence of behavioral disturbances, defined as a Neuropsychiatric Inventory (NPI) total score of 24 or higher, or a score of 12 in at least one NPI symptom domain. * No clinical condition at hospital admission that would prevent delivery of the non-pharmacological intervention, including isolation for SARS-CoV-2 infection or another condition requiring isolation, deep sedation, coma, or severe respiratory failure. * Written informed consent provided by the participant, when capable of providing consent, or by the participant's legal guardian or legally authorized representative. * Written informed consent provided by the caregiver. Exclusion Criteria: * Age younger than 65 years. * No diagnosis of dementia or delirium. * No available caregiver, or caregiver unwilling or unable to participate in the education program. * NPI total score lower than 24 and no individual NPI symptom domain score of 12. * Clinical condition present at admission or developing during hospitalization that prevents delivery of the non-pharmacological intervention, including isolation for SARS-CoV-2 infection or another condition requiring isolation, deep sedation, coma, or severe respiratory failure. * Informed consent not obtained from the participant, when capable of providing consent, or from the participant's legal guardian or legally authorized representative. * Informed consent not obtained from the caregiver.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ospedale Civile di Baggiovara
Modena, Emilia-Romagna, 41124, Italy
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