Effects of Snoezelen Multisensory Therapy on Older Adults With Dementia

NCT07657208 | Completed

• 2 other identifiers: UPrimosrka0120-104/2020/6
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Dementia

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

Outcome Measures

Primary Outcomes (9)

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

  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.

  Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12

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

  The CSDD assesses signs of depression in individuals with dementia. Scores range from 0 to 38, with higher scores indicating more severe depression.

  Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12

• Change in anxiety level (HADS-Anxiety Subscale)

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

  Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12

• Change in heart rate

  Heart rate is measured using wearable physiological sensors as an indicator of autonomic arousal and physiological response.

  Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)

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

  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.

  Immediately before and immediately after each SMT session, three times per week for 12 weeks (36 sessions total)

• Change in heart rate variability (HRV)

  Heart rate variability (HRV) is measured using wearable physiological sensors as an indicator of autonomic nervous system regulation and physiological response to therapy.

  Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)

• Change in skin conductance

  Skin conductance is measured using wearable physiological sensors as an indicator of autonomic arousal and stress response

  Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)

• Change in oxygen saturation (SpO₂)

  Peripheral oxygen saturation (SpO₂) is measured using wearable physiological sensors as an indicator of oxygenation status during therapy.

  Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)

• Change in salivary cortisol concentration

  Salivary cortisol concentration is measured as a physiological biomarker of stress and hypothalamic-pituitary-adrenal (HPA) axis activity.

  Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)

Study Arms (2)

SMT + Standard Therapy

EXPERIMENTAL

Participants in this group will receive standard therapy routinely provided at the care center in addition to Snoezelen Multisensory Therapy (SMT). SMT will be delivered individually in a Snoezelen-designed multisensory room for 30 minutes, three times per week, over a 12-week period. Sessions will be tailored to each participant's sensory profile and preferences.

Behavioral: Snoezelen Multisensory Therapy; Behavioral: Standard Therapy

Standard Therapy Only

ACTIVE COMPARATOR

Participants in this group will receive standard therapy routinely provided at the care center, including cognitive stimulation activities (e.g., memory games, orientation exercises, attention and problem-solving tasks), group social interactions, occupational therapy, physical therapy, creative activities (e.g., art and music sessions), reminiscence therapy, and relaxation practices. No Snoezelen Multisensory Therapy (SMT) will be provided.

Behavioral: Standard Therapy

Interventions

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.

Also known as: SMT, Multisensory stimulation, MSS, Snoezelen

SMT + Standard Therapy

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.

Also known as: ST, Routine care, Cognitive Training, Occupational Therapy, Group Social Engagement

SMT + Standard Therapy; Standard Therapy Only

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Primorska: lead

Study Sites (1)

Center for Older Adults Lucija

Portorož, 6320, Slovenia

Location

MeSH Terms

Conditions

Dementia; Behavior; Cognitive Dysfunction; Psychomotor Agitation; Depression

Interventions

Standard of Care; Cognitive Training; Occupational Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No parties are blinded in this study due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 18, 2026
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)