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Completed

NCT Number: NCT07657208

Effects of Snoezelen Multisensory Therapy on Older Adults With Dementia

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 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.

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Key information

Conditions

Dementia Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Depression Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Older Adults Lucija

Portorož, 6320, Slovenia

About this study

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 60 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 65 years or older

Diagnosed dementia (any subtype)

Montreal Cognitive Assessment (MoCA) score between 10-25

Katz Performance Status Score (KPSS) 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

Treatment and study plan

Snoezelen Multisensory Therapy

Behavioral

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.

Other names: SMT, Multisensory stimulation, MSS, Snoezelen

Standard Therapy

Behavioral

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.

Other names: ST, Routine care, Cognitive Training, Occupational Therapy, Group Social Engagement

Primary outcomes

  1. Change in agitation level as measured by Cohen-Mansfield Agitation Inventory (CMAI)

    Time frame: 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.

  2. Change in depressive symptoms as measured by Cornell Scale for Depression in Dementia (CSDD)

    Time frame: 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.

  3. Change in anxiety level (HADS-Anxiety Subscale)

    Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12

    HADS-A is a validated subscale that measures anxiety in older adults. Scores range from 0 to 21, with higher values indicating greater anxiety.

  4. Change in heart rate

    Time frame: 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.

  5. Change in subjective well-being using a self-reported analog scale

    Time frame: 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 0 to 5 before and after each SMT session.

  6. Change in heart rate variability (HRV)

    Time frame: 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.

  7. Change in skin conductance

    Time frame: 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

  8. Change in oxygen saturation (SpO₂)

    Time frame: 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.

  9. Change in salivary cortisol concentration

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Primorska

Other

Registry information

Official study title

Randomized Controlled Trial on the Effects of Snoezelen Multisensory Therapy on Behavioral, Psychological, and Physiological Symptoms in Older Adults With Dementia

Acronym: SMT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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