Dementia
Conditions
Keywords
Dementia, Behavioral and Psychological Symptoms of Dementia, BPSD, Snoezelen, Multisensory Therapy, SMT, Non-pharmacological therapy, Heart rate variability, Salivary cortisol, Elderly, Cognitive decline, Agitation, Depression, Physiological markers, AD
Brief summary
This randomized, controlled, longitudinal clinical trial investigates the effects of Snoezelen Multisensory Therapy (SMT) as an adjunct to standard therapy (ST) in older adults with dementia. Sixty-three participants with mild to moderate cognitive impairment and behavioral and psychological symptoms of dementia (BPSD) will be recruited from the Center for Older Adults Lucija (Slovenia). Participants will be randomized into two groups: control (ST) and experimental (ST + SMT). SMT will be administered 3 times per week for 12 weeks. Primary outcomes include changes in agitation (CMAI), depression (CSDD), anxiety (HADS), physiological indicators (heart rate, HR variability, SpO2, skin conductance, salivary cortisol), and frequency of psychiatric medication use. Subjective well-being will also be tracked before and after each session.
Detailed description
Dementia is a growing public health concern, with high rates of behavioral and psychological symptoms (BPSD), such as depression, agitation, and anxiety. Non-pharmacological therapies like Snoezelen Multisensory Therapy (SMT) are increasingly explored as safe and effective alternatives or complements to standard therapy (ST). This randomized controlled clinical trial will evaluate the acute and chronic effects of SMT in 63 patients with dementia at the Center for Older Adults Lucija, Slovenia. Participants will be stratified by medication use and cognitive status and randomly assigned to either an experimental group receiving SMT + ST, or a control group receiving ST alone. SMT consists of 30-minute sessions in a multisensory room equipped according to Snoezelen® guidelines. Sessions will be personalized and monitored, including physiological measurements before and after therapy. Primary outcomes will include changes in BPSD measured by the Cornell Scale for Depression in Dementia (CSDD), the Hospital Anxiety and Depression Scale (HADS), and the Cohen-Mansfield Agitation Inventory (CMAI). Physiological indicators such as heart rate (HR), heart rate variability (HRV), oxygen saturation (SpO2), skin conductance, and salivary cortisol will be collected before and after the 1st and 36th sessions. Medication use (PRN) will be tracked every two weeks. The study includes translation and validation of BPSD assessment tools into Slovenian. Results are expected to contribute valuable data to the field of dementia care and support broader implementation of SMT in geriatric settings. This study was registered retrospectively on ClinicalTrials.gov after study completion.
Interventions
BEHAVIORALSnoezelen Multisensory Therapy
A non-pharmacological, individualized sensory stimulation therapy delivered in a Snoezelen-designed multisensory environment. Sessions include visual, auditory, tactile, and olfactory stimuli tailored to the participant's sensory profile and preferences. The intervention is delivered individually for 30 minutes, three times per week, over a 12-week period and is intended to reduce behavioral and psychological symptoms of dementia and improve well-being.
BEHAVIORALStandard Therapy
Standard therapy refers to routine care provided in the residential care setting and includes cognitive stimulation activities, group social interactions, occupational therapy, physical therapy, creative activities (e.g., art and music sessions), reminiscence therapy, and relaxation practices. These interventions are delivered by trained staff as part of the regular care program. No Snoezelen Multisensory Therapy or other multisensory stimulation interventions are provided as part of standard therapy.
Sponsors
University of Primorska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No parties are blinded in this study due to the nature of the intervention.
Intervention model description
Participants will be randomly assigned to one of two parallel arms. The intervention arm will receive Snoezelen Multisensory Therapy (SMT) in addition to standard therapy.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age 65 years or older Diagnosed dementia (any subtype) Montreal Cognitive Assessment (MoCA) score between 10-25 Mini Mental State Examination (MMSE) between 10-24 Behavioral and psychological symptoms of dementia (BPSD), indicated by at least one of the following: Cornell Scale for Depression in Dementia (CSDD) score \>10 Hospital Anxiety and Depression Scale (HADS) score \>8 Cohen-Mansfield Agitation Inventory (CMAI) showing moderate or severe symptoms Ability to follow basic instructions and communicate needs Written informed consent obtained from the participant or their legal representative
Exclusion criteria
* Acute psychiatric illness or unstable somatic condition Severe visual or hearing impairments Inability to communicate in Slovenian Concurrent participation in psychotherapy or physiotherapy Diagnosis of epilepsy Changes to psychiatric medication within 4 weeks prior to study start Any other condition that, in the opinion of the research team, would interfere with participation or data collectio
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in oxygen saturation (SpO₂) | Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12) | Peripheral oxygen saturation (SpO₂) is measured using wearable physiological sensors as an indicator of oxygenation status during therapy. |
| Change in salivary cortisol concentration | Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12) | Salivary cortisol concentration is measured as a physiological biomarker of stress and hypothalamic-pituitary-adrenal (HPA) axis activity. |
| Change in agitation level as measured by Cohen-Mansfield Agitation Inventory (CMAI) | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12 | The Cohen-Mansfield Agitation Inventory (CMAI) is used to measure the frequency of agitated behaviors in elderly participants with dementia. Scores range from 29 to 203, with higher scores indicating more frequent agitation. |
| Change in depressive symptoms as measured by Cornell Scale for Depression in Dementia (CSDD) | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12 | The CSDD assesses signs of depression in individuals with dementia. Scores range from 0 to 38, with higher scores indicating more severe depression. |
| Change in anxiety and depression level measured with the Hospital Anxiety and Depression Scale (HADS) | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12 | HADS is a validated subscale that measures anxiety and depression in older adults. Scores range from 0 to 21, with higher values indicating greater anxiety. |
| Change in heart rate | Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12) | Heart rate is measured using wearable physiological sensors as an indicator of autonomic arousal and physiological response. |
| Change in subjective well-being using a self-reported analog scale | Immediately before and immediately after each SMT session, three times per week for 12 weeks (36 sessions total) | Participants report their mood, comfort, and overall well-being on a self-reported visual analog scale ranging from 1 to 5 before and after each SMT session. |
| Change in heart rate variability (HRV) | Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12) | Heart rate variability (HRV) is measured using wearable physiological sensors as an indicator of autonomic nervous system regulation and physiological response to therapy. |
| Change in skin conductance | Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12) | Skin conductance is measured using wearable physiological sensors as an indicator of autonomic arousal and stress response |
Countries
Slovenia
Outcome results
None listed